QA/ QC Director

Job Description Job Posting TitleDirector of Quality Assurance / Quality Control (QA/QC Director)Job DescriptionCompanyOcyonBio 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.Place of PerformanceCII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603Job OverviewThe 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).ResponsibilitiesQuality Management & Strategic OversightLead daily QA and QC operations to ensure sustained FDA cGMP complianceEstablish, implement, and continuously improve the Quality Management System (QMS)Ensure effective implementation of SOPs, policies, and quality procedures across departmentsDevelop quality metrics, dashboards, and management review processesSupport continuous inspection readinessDrive cross-functional quality alignment within a startup growth environmentQuality Assurance OversightReview and approve complex or high-risk:Batch records and disposition decisionsDeviations and investigationsChange controlsCAPAs and effectiveness checksEnsure timely and compliant batch dispositionProvide QA oversight for manufacturing and laboratory operationsOversee validation and qualification activities including:Equipment, utilities, and facilitiesProcess validationComputerized systems validation (CSV)Ensure supplier qualification processes and quality agreements are effectively implementedQuality Control OversightProvide leadership and oversight of QC laboratory operations including:Analytical release and stability testingMicrobiology testing (sterility, endotoxin, bioburden)Environmental monitoringUtilities and facilities monitoringEnsure QC data integrity in accordance with ALCOA+ principlesOversee investigations for OOS, OOT, and atypical resultsEnsure appropriate trending and evaluation of laboratory and environmental dataDigital Systems & AI GovernanceEnsure computerized systems used in QA/QC activities remain qualified and validatedApply risk-based validation approaches consistent with Part 11 and GAMP 5Support governance of AI-enabled or automated tools used in GMP activities, ensuring:Defined intended useAppropriate human oversightFormal change control managementMaintain awareness of emerging regulatory expectations related to AI in GMP environmentsInspections & Regulatory LeadershipLead QA/QC preparation for FDA inspections and client auditsServe as senior quality representative during inspectionsReview and approve inspection responses and corrective action plansEnsure sustainable inspection readiness through internal audits and risk managementCDMO Client SupportServe as senior quality interface for CDMO clientsOversee review of CMC-related QC data and quality documentationParticipate in client audits and technical discussionsEnsure regulatory compliance while meeting client commitmentsEducation / QualificationsRequiredBachelor's degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific discipline10+ years of GMP experience in biologics or sterile manufacturing5+ years of progressive leadership experience in QA, QC, or combined QA/QC functionsExperience overseeing both QA and QC operationsExperience leading or hosting FDA inspectionsPreferredMaster's degree in scientific or engineering disciplineCDMO or multi-client manufacturing experienceExperience building or scaling a QMS in a startup or growth environmentExperience with computerized systems validation (CSV)Familiarity with AI/ML applications in regulated environmentsTechnical SkillsExpert 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 integrityKnowledge of ALCOA+, Part 11, and GAMP 5Strong leadership and cross-functional collaboration skillsStrategic decision-making and risk-based judgmentExcellent written and verbal communication skillsWorking ConditionsThis 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.Physical RequirementsAbility to stand and walk for extended periods during facility oversight activitiesAbility to wear required PPE, including gowning for classified cleanroom environmentsAbility to access and work within GMP manufacturing and laboratory areasVisual acuity to review detailed documentation and electronic recordsAbility to use computers and digital systems for extended periodsAbility 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 EmployerOcyonBio 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