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

• Master’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: