Director GMP Quality Assurance

Description

Job Purpose

Director, GMP Quality Assurance (QA) is responsible for the quality compliance of drug substance, drug product and packaging sited for all Ocugen products. The Director GMP QA will ensure GMP compliance, regulatory inspection readiness, and continuous improvement across clinical, R&D and commercial manufacturing operations with Ocugen and Ocugen’s business partners. This Director, GMP Quality role is a high-impact leadership position that is responsible for global GMP compliance, quality excellence, and operational oversight across internal and external stake holders, develop and lead internal and external GMP audits, Pre-approval Inspection readiness, Implementation of QP for batch release in EU member states.

This position will play a critical role in quality assurance (QA) leadership, overseeing GMP operations, vendor quality management, batch record release, investigations, deviations, CAPAs, change controls, stability programs, and audits. The ideal candidate will have extensive experience in biologics, strong regulatory knowledge, and a proven ability to drive compliance and quality culture across internal and external partners.

Responsibilities

Regulatory Compliance & Inspection Readiness

• Lead inspection readiness activities, including mock inspections, on-site regulatory audits, and remediation efforts.
• Serve as the primary GMP QA contact during regulatory inspections (FDA, EMA, MHRA, Health Canada, etc.).
• Ensure GMP compliance across internal and external manufacturing, testing, and warehousing operations.
• Stay up to date with global GMP regulations and ensure Ocugen’s policies align with evolving regulatory expectations.
• Support root cause analysis (RCA) for deviations, out-of-specification (OOS), out-of-trend (OOT), and other quality events.

Quality Oversight & Vendor Management

• Define and implement GMP quality standards, procedures, and work instructions to drive high compliance levels at Ocugen and CMOs.
• Provide quality oversight of contract manufacturers (CDMOs), participating in Review Meetings to identify and mitigate quality risks.
• Oversee quality agreements, supplier qualifications, and vendor audits to ensure partners meet Ocugen’s GMP standards.
• Review and approve master batch records, executed batch records, analytical methods, protocols, change controls, deviations, CAPAs, and investigations.
• Partner with Supply Chain, Pharmaceutical Technology, and Regulatory Affairs to ensure vendor quality compliance.

Cross-Functional Leadership & Risk Management

• Act as the lead QA partner for drug substance, drug product, and packaging operations, ensuring end-to-end compliance.
• Oversee GMP risk management programs to proactively identify and mitigate compliance risks.
• Implement and lead internal audit programs, including follow-up on CAPAs and timely closure of corrective actions.
• Drive continuous process improvement initiatives in quality operations, manufacturing, and analytical testing.
• Collaborate with cross-functional teams for regulatory inspections impacting GMP activities.
• Maintain up-to-date knowledge of global cGMP regulations.

People Leadership & Training

• Develop and mentor GMP QA teams, fostering a culture of compliance, continuous improvement, and innovation.
• Train employees on global GMP regulations, quality standards, and best practices.
• Establish clear quality goals, metrics, and accountability to drive organizational performance and compliance.

Qualifications

• Bachelor’s or Master’s degree in Biology, Chemistry, or related field.
• 10 years of experience of leading in Quality Assurance organization in the biopharmaceutical/biotech industry.
• 5 years of direct experience with health authority inspections (FDA, EMA, MHRA, Health Canada, etc.).
• Extensive experience in biologics, vaccines, or gene therapy products.
• Strong knowledge of GMP regulations (FDA, EU, ICH, WHO, USP, PMDA) and industry best practices.
• Experience in batch record release, investigations, CAPAs, deviations, and change control oversight.
• Proven track record of managing CMOs, regulatory inspections, and continuous quality improvement initiatives.
• Strong problem-solving, leadership, and strategic planning skills.
• Proficiency in quality management systems (QMS), including Veeva Vault (QualityDocs, Training, eQMS, RIM, etc.).

Working Conditions

• Incumbent will primarily work Monday – Friday during normal business hours onsite in an office environment.

Direct Reports

• This position will have direct reports in US and India

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.