Director of Quality Assurance / Quality Control (QA/QC Director)
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory and systems capabilities and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603
The Director of Quality Assurance / Quality Control (QA/QC Director) is responsible for the strategic leadership, operational oversight, and performance management of both QA and QC functions supporting aseptic manufacturing, analytical and microbiology laboratories, and CDMO client programs.
This role ensures compliance with FDA cGMP requirements (21 CFR Parts 210, 211, and Part 11) while supporting inspection readiness, scalable quality system implementation, and compliant data generation.
As a senior leader in a growing startup environment, the QA/QC Director is responsible for strengthening and scaling the Quality Management System (QMS) to support clinical and commercial operations.
The QA/QC Director operates under the direction of the Head of Quality and supports operational sterility controls in alignment with the site’s established sterility assurance and Contamination Control Strategy (CCS).
Lead daily QA and QC operations to ensure sustained FDA cGMP compliance
Establish, implement, and continuously improve the Quality Management System (QMS)
Ensure effective implementation of SOPs, policies, and quality procedures across departments
Develop quality metrics, dashboards, and management review processes
Support continuous inspection readiness
Drive cross-functional quality alignment within a startup growth environment
Review and approve complex or high-risk:
Batch records and disposition decisions
Deviations and investigations
Change controls
CAPAs and effectiveness checks
Ensure timely and compliant batch disposition
Provide QA oversight for manufacturing and laboratory operations
Oversee validation and qualification activities including:
Equipment, utilities, and facilities
Process validation
Computerized systems validation (CSV)
Ensure supplier qualification processes and quality agreements are effectively implemented
Provide leadership and oversight of QC laboratory operations including:
Analytical release and stability testing
Microbiology testing (sterility, endotoxin, bioburden)
Environmental monitoring
Utilities and facilities monitoring
Ensure QC data integrity in accordance with ALCOA+ principles
Oversee investigations for OOS, OOT, and atypical results
Ensure appropriate trending and evaluation of laboratory and environmental data
Ensure computerized systems used in QA/QC activities remain qualified and validated
Apply risk-based validation approaches consistent with Part 11 and GAMP 5
Support governance of AI-enabled or automated tools used in GMP activities, ensuring:
Defined intended use
Appropriate human oversight
Formal change control management
Maintain awareness of emerging regulatory expectations related to AI in GMP environments
Lead QA/QC preparation for FDA inspections and client audits
Serve as senior quality representative during inspections
Review and approve inspection responses and corrective action plans
Ensure sustainable inspection readiness through internal audits and risk management
Serve as senior quality interface for CDMO clients
Oversee review of CMC-related QC data and quality documentation
Participate in client audits and technical discussions
Ensure regulatory compliance while meeting client commitments
Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific discipline
10+ years of GMP experience in biologics or sterile manufacturing
5+ years of progressive leadership experience in QA, QC, or combined QA/QC functions
Experience overseeing both QA and QC operations
Experience leading or hosting FDA inspections
PreferredMaster’s degree in scientific or engineering discipline
CDMO or multi-client manufacturing experience
Experience building or scaling a QMS in a startup or growth environment
Experience with computerized systems validation (CSV)
Familiarity with AI/ML applications in regulated environments
Expert knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, and 11)
Working knowledge of EU GMP principles (Annex 1 familiarity preferred)
Strong understanding of GMP laboratory operations and data integrity
Knowledge of ALCOA+, Part 11, and GAMP 5
Strong leadership and cross-functional collaboration skills
Strategic decision-making and risk-based judgment
Excellent written and verbal communication skills
This position operates in a GMP manufacturing and laboratory environment. The role requires routine presence in classified cleanroom areas and laboratories.
May require extended hours to support inspections, investigations, or critical manufacturing operations.
Ability to stand and walk for extended periods during facility oversight activities
Ability to wear required PPE, including gowning for classified cleanroom environments
Ability to access and work within GMP manufacturing and laboratory areas
Visual acuity to review detailed documentation and electronic records
Ability to use computers and digital systems for extended periods
Ability to occasionally lift up to 20 pounds (documents, binders, equipment samples)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Read LessJob Posting Title
Cleaning Operator Team Lead
Job Description
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
The Cleaning Lead will play a critical role in the start-up and ongoing support of OcyonBio’s GMP cleanroom operations. This individual will be responsible for establishing, executing, and maintaining compliant cleaning and sanitation programs for new cleanroom facilities supporting parenteral manufacturing operations. The role requires a strong hands-on presence, deep understanding of cleanroom behaviors, and the ability to build and lead a high-performing cleaning team in a startup environment. We are looking for a motivated, detail-oriented professional with strong cleanroom experience who is comfortable working hands-on while helping to build systems and teams in a fast-paced startup environment.
Key responsibilities:
• Lead the start-up and implementation of GMP-compliant cleaning and sanitation programs for newly constructed cleanrooms.
• Establish routine and non-routine cleaning schedules, procedures, and workflows for classified manufacturing areas (e.g., ISO 5–8).
• Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices.
• Support cleaning validation activities, including execution of protocols, sampling activities, and documentation.
• Author, review, and execute SOPs, logbooks, and cleaning records in compliance with Quality Systems.
• Recruit, train, and develop the cleanroom cleaning team, setting expectations for performance, compliance, and cleanroom behavior.
• Train personnel on gowning practices, aseptic techniques, contamination control, and proper use of cleaning agents and equipment.
• Ensure proper handling, preparation, and storage of approved cleaning and disinfecting agents.
• Collaborate cross-functionally with Quality, Facilities, Engineering, and Manufacturing to support operational readiness and inspection preparedness.
• Support deviation investigations, CAPAs, and continuous improvement initiatives related to cleaning and contamination control.
• Demonstrate flexibility and a “roll-up-the-sleeves” mindset to meet evolving operational needs typical of a startup organization.
Basic Qualifications:
• High school diploma or equivalent required; additional technical or life sciences education preferred.
• Minimum of 3 years of hands-on experience working in GMP cleanroom environments.
• Direct experience supporting cleaning and sanitation activities in classified areas.
• Strong understanding of cleanroom behaviors, gowning, and contamination control principles.
Preferred Qualifications:
• Experience in parenteral or aseptic manufacturing operations.
• Prior experience supporting cleanroom start-up or facility commissioning activities.
• Experience training and leading cleaning or facilities support personnel.
• Working knowledge of FDA cGMP regulations, aseptic processing guidelines, and industry best practices.
• Familiarity with cleaning validation concepts and environmental monitoring interfaces.
• Strong documentation skills and attention to detail.
• Ability to work independently, prioritize tasks, and adapt in a startup environment.
What we offer:
Competitive salary (DOE.)Health, dental, and vision benefits.Professional training and development opportunities.Opportunities to participate in the company stock options programWe Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Read LessJob description: QA Specialist
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.Role SummaryProvides strategic and technical leadership for the Pharmaceutical Quality System, ensuring robust quality oversight of facility start-up, technology transfer, analytical method transfer, manufacturing process transfer, and sustained commercial GMP operations.
Key ResponsibilitiesProvide strategic QA leadership aligned with ICH Q10 principlesLead high-impact quality risk assessments and CAPA programsOversee quality aspects of technology transfer and process lifecycle managementSupport regulatory inspections, submissions, and client auditsMentor QA staff and drive continuous improvement initiativesQualificationsBachelor’s degree required; advanced degree preferredAt least 5-8 years of QA experience in sterile biologics manufacturingDemonstrated leadership in quality systems and regulatory interactionsCore CompetenciesStrong quality mindset aligned with ICH Q10 Pharmaceutical Quality System principlesRisk-based decision making (ICH Q9) and lifecycle approach to qualityExcellent GMP documentation and data integrity practicesCross-functional collaboration in start-up and technology transfer environmentsContinuous improvement and inspection readiness focusWe Are An Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Job Title: Sterility Assurance Lead
Location: CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603
About OcyonBio
OcyonBio is a biotechnology company based in Aguadilla, Puerto Rico, providing flexible cGMP manufacturing spaces and integrated quality and technical services to support the development, manufacture, and commercialization of biologics, gene therapies, and cell therapies.
Operating as a cGMP incubator, OcyonBio maintains robust quality systems, regulatory oversight, and technical expertise to generate CMC data suitable for global regulatory submissions. We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong culture of quality, contamination control, and continuous improvement.
Job Overview
The Sterility Assurance Lead is accountable for ensuring that aseptic processing systems and sterility assurance controls are designed, implemented, monitored, and maintained in a validated state of control, in alignment with FDA Aseptic Processing Guidance, EU GMP Annex 1, and applicable ICH guidelines. This role owns the Contamination Control Strategy (CCS) and provides site-level technical leadership to ensure contamination risks are systematically identified, scientifically assessed, and effectively mitigated throughout the facility and product lifecycle. The Sterility Assurance Lead serves as the primary subject matter expert during regulatory inspections and drives inspection-ready, data-supported decision making.
Key Responsibilities
· Own, implement, and continuously improve the site Contamination Control Strategy (CCS), ensuring it is comprehensive, risk-based, and maintained throughout the lifecycle of facilities, utilities, equipment, processes, and products.
· Ensure aseptic processing controls are scientifically justified, data-driven, and demonstrably effective, maintaining a consistent state of control.
· Provide sterility assurance oversight for aseptic processing operations, including gowning qualification, aseptic behaviors, personnel training, and cleanroom practices.
· Collaborate cross-functionally with Operations, QC Microbiology, Engineering, and Validation to establish and maintain environmental monitoring, clean util-ity, cleaning, and sanitization programs, including justified alert/action limits and response strategies.
· Review, trend, and interpret microbiological and environmental monitoring data to identify adverse trends, emerging risks, and opportunities for risk reduction.
· Lead or provide expert input into microbiological investigations, contamination events, sterility failures, and environmental excursions, ensuring thorough root cause analysis and effective CAPAs.
· Ensure CAPAs are timely, sustainable, and verified for effectiveness, with documentation suitable for FDA and EMA inspection.
· Provide technical oversight for microbiological method transfers, validation, and verification, ensuring methods are fit for intended use.
· Act as the primary Sterility Assurance Subject Matter Expert during FDA, EMA, and other regulatory inspections and audits, presenting contamination control strategies, data trending, investigations, and risk assessments.
· Promote a strong contamination control culture through routine floor presence, coaching, training, and proactive quality engagement.
· Support continuous improvement initiatives and ensure sterility assurance considerations are embedded within change management and validation activities.
Education & Experience
· Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific discipline (Master’s degree preferred).
· Minimum 5 years of experience in pharmaceutical or biopharmaceutical manufacturing within a GMP environment.
· Demonstrated experience supporting aseptic sterile manufacturing operations.
· Prior experience in microbiology, sterility assurance, or contamination control roles required.
· Strong working knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1 (2022), 21 CFR Parts 210/211, and ICH Q7, Q9, and Q10.
· Proven experience supporting FDA and/or EMA regulatory inspections.
Technical & Professional Competencies
· Ability to apply Quality Risk Management (ICH Q9) principles to sterility assurance and contamination control decisions.
· Strong analytical and data-trending skills with the ability to scientifically justify controls, mitigations, and conclusions.
· Experience leading complex investigations and driving effective, sustainable CA-PAs to closure.
· Strong communication and influencing skills, including direct interaction with regulators and auditors.
· Ability to balance regulatory compliance, product quality, and operational efficiency.
Working Conditions
· Work in classified cleanroom environments requiring aseptic gowning and strict contamination control practices.
· Travel may be required to support vendor qualification activities, FAT/SAT execution, and regulatory or client audits.
· Flexibility to support extended hours or weekend work during validation, inspections, or critical manufacturing activities.
Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without restate,to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. To learn more about us, please visit our website: https://ocyonbio.com
Read LessJob Title: Validation Manager
About Ocyonbio:
OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico, providing flexible cGMP facilities and integrated services to accelerate the development, manufacturing, and commercialization of biologics, cell & gene therapies, and advanced pharmaceutical products. Operating as a cGMP incubator-style environment, OcyonBio enables robust CMC data generation to support global regulatory submissions. We are committed to fostering an inclusive, respectful workplace where integrity, collaboration, and technical excellence are core to everything we do.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
OcyonBio is seeking a Validation Manager to establish, lead, and govern the site Validation Program, including full ownership of the Site Master Validation Plan (SMVP). This role is responsible for ensuring that facilities, utilities, and manufacturing equipment are initially qualified, periodically requalified, and maintained in a validated state throughout their lifecycle in a multi-client CDMO environment.
The Validation Manager provides both hands-on technical leadership and strategic oversight, leading teams of company employees and contract personnel, and serving as the validation subject matter expert during regulatory inspections and client audits.
The Validation Manager is also expected to actively and continuously leverage AI-enabled tools and digital technologies to improve validation planning, execution, documentation quality, trend analysis, and inspection readiness, while ensuring full compliance with cGMP and data integrity requirements.
Key Responsibilities:
Validation Program & Governance
Establish, lead, and maintain the sitewide Validation ProgramDevelop, approve, and govern the Site Master Validation Plan (SMVP)Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioningCoordinate initial qualification, periodic requalification, and change-driven revalidation activitiesFacility & Utility Qualification
Lead validation and qualification of:Cleanrooms and HVAC systemsWFI, purified water, clean steam, and compressed gas systemsEnvironmental monitoring systemsImplement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelinesEnsure facility systems remain in a validated state and inspection-readyEquipment Startup & Qualification
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:Sterile filling lines, autoclaves, incubators, refrigerators, and freezersBioreactors, chromatography skids, and single-use systems (SUS)Solid dosage equipment (granulators, tablet presses, coating systems)Oversee FAT/SAT planning and executionApprove IQ/OQ/PQ protocols, reports, and traceability matricesTeam & Resource Leadership
Lead validation activities performed by company employees and contract validation personnelBuild, train, and manage validation resources to support project and operational needsOversee vendor qualification and validation service providersDigital Enablement & AI Utilization
Consistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvementApply AI tools to improve efficiency, consistency, and quality of validation documentation and data reviewEnsure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policiesIdentify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory complianceCompliance & Inspection Readiness
Ensure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirementsServe as Validation SME during regulatory inspections and client auditsLead deviation investigations, impact assessments, and CAPAs related to validation activitiesEnsure data integrity compliance, including 21 CFR Part 11Cross-Functional Collaboration
Partner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project executionSupport technology transfers, facility expansions, and new client onboardingTrain operations and quality personnel on validation expectations, procedures, and digital toolsQualifications:
Education & Experience
Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environmentsDemonstrated experience leading site-level validation programs and supporting regulatory inspectionsTechnical Expertise
Cleanroom and critical utility qualificationAseptic processing and sterilization validationEquipment commissioning and lifecycle validationRisk-based validation (ASTM E2500)Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirementsDemonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environmentsLeadership & Soft Skills
Strong technical writing and documentation skillsExcellent problem-solving and decision-making abilitiesEffective communicator with strong cross-functional collaboration skillsAbility to lead in a fast-paced, multi-client CDMO environmentPreferred Qualifications
Lean Six Sigma, ASQ CQE, or ISPE certificationExperience with EU GMP Annex 1 (Sterility Assurance)Hands-on exposure to single-use bioprocessing and viral vector manufacturingExperience implementing or using AI tools within regulated GxP environmentsWorking Conditions
Work in classified cleanroom environments with aseptic gowningTravel may be required for FAT/SAT, vendor audits, and client engagementsFlexibility to support extended hours or weekends during critical validation phasesWhat we offer:
Competitive compensation and benefitsHealth, dental, and vision insuranceProfessional training and development opportunitiesEligibility for company stock option programsOpportunity to help build and shape a growing CDMOWe Are An Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
To learn more about us, please visit our website: https://ocyonbio.com
