Head, Quality Assurance & Regulatory

Head of Quality Assurance & Regulatory Affairs

• Strategic Leadership: Develop and implement a comprehensive global quality and regulatory strategy for the company to ensure successful clinical development, market authorization and operations. Lead PPQ strategy for process validation, assay validation, shipping validation, and stability programs specific to Gell & Gene Therapy.
• Regulatory Submissions & Compliance: Oversee the preparation, submission, and maintenance of all regulatory filings (INDs, BLAs, MAAs, etc.) and serve as the primary liaison with global and Indian health authorities
• Quality Management Systems (QMS): Initiate, implement, and enforce a robust QMS that is compliant with cGMP, GLP, and GCP regulations. Drive continuous improvement of quality systems using forward-looking technologies.
• Audits & Inspections: Lead site operational readiness for regulatory inspections and client audits. Manage inspection responses and ensure timely implementation of corrective and preventive actions (CAPAs).
• Operational Quality Oversight: Maintain stringent quality oversight of manufacturing operations, product testing, raw material release, and final product disposition. Establish phase-appropriate quality pathways for early-stage, pivotal, and commercial manufacturing. Lead governance for deviations, CAPA, OOS/OOT, change controls, risk assessments (FMEA), and batch disposition. Oversee digital QMS, data integrity (ALCOA+), and electronic batch record implementations suitable for large-scale operations.
• Risk Management: Evaluate and analyze potential regulatory impacts, conduct global regulatory risk assessments, and develop mitigation strategies to ensure compliance and minimize risks.
• Team Leadership & Development: Build, lead, and mentor high-performing QA and RA teams. Foster a culture of quality, compliance, collaboration, and operational excellence.
• Cross-functional Collaboration: Partner closely with R&D, Clinical, CMC, Nonclinical, and Manufacturing teams to ensure clear, compliant, and scientifically sound communication and processes across the organization.

Qualifications:

• Masters in Science/Pharmacy or PhD in Sciences with 10+ years in the pharmaceutical/biotechnology industry with minimum 5 years in a leadership role managing Quality and/or Regulatory teams.
• Experience in Biologics, Sterile Injectables, or Advanced Therapy Medicinal Products (ATMPs). Experience specifically with Cell & Gene therapy is preferred.
• Demonstrated experience in successful regulatory submissions.
• Experience working across the full product lifecycle, from early-phase clinical trials (Phase I/II) through to pivotal trials (Phase III) and commercial launch.
• Proven hands-on experience developing PPQ strategies for complex biological processes, including assay validation, cold-chain/shipping validation, and stability studies.
• "Quality Culture" Champion: The ability to influence non-quality stakeholders (R&D, Operations) to adopt quality standards, with high emotional intelligence and persuasion skills.
• Ability to provide hands-on leadership, willing to work in individual capacity on certain specific initiatives.
• Cross-Cultural Communication: Ability to seamlessly bridge the gap between local operational teams (India) and global regulatory bodies/partners.