We are seeking a seasoned and visionary Head of Quality to lead our Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs (RA) departments. The ideal candidate will bring deep expertise in pharmaceutical manufacturing standards, global regulatory compliance, and quality systems implementation, preferably gained in a foreign multinational environment.

This is a strategic leadership role that will shape the quality culture of the organization, ensure compliance with international regulations (GMP, ICH, WHO, USFDA, EMA), and drive continuous improvement across all operations.

Key Responsibilities:

Strategic Leadership & Quality Governance

- Lead and manage the QA, QC, and RA teams to ensure compliance with global regulatory frameworks and GMP standards.

- Provide strategic direction and oversight for all quality operations, including product lifecycle compliance, risk management, and regulatory submissions.

Quality Systems & Compliance

- Establish, implement, and sustain robust quality systems, SOPs, and documentation practices in line with national and international regulatory authorities.

- Ensure consistent readiness for regulatory inspections (USFDA, EMA, WHO, CDSCO, etc.) and customer audits.

Audit & CAPA Management

- Lead internal, external, and regulatory audits, ensuring timely and effective CAPA (Corrective and Preventive Action) planning and execution.

- Champion a risk-based approach to deviation management, change control, and root cause analysis.

Cross-Functional Collaboration

- Collaborate closely with Manufacturing, R&D, Supply Chain, and Engineering teams to ensure consistent delivery of quality outcomes.

- Ensure technology transfers, scale-up activities, and new product launches meet global quality and compliance standards.

Talent Development & Culture Building

- Mentor and guide senior managers across QA, QC, and RA to build high-performing, inspection-ready teams.

- Promote a culture of quality, accountability, and continuous improvement across all levels of the organization.

Regulatory Affairs

- Provide high-level oversight of regulatory submissions, licensing, renewals, and interactions with health authorities.

- Keep the leadership informed of regulatory changes, risks, and emerging compliance challenges.

Reporting & Risk Management

- Regularly report quality metrics, risk assessments, and compliance status to senior leadership and the board.

- Act as the chief spokesperson during regulatory inspections and external audits.

Candidate Profile:

- Minimum 25 years of progressive experience in pharmaceutical quality functions (QA/QC/RA), with at least 5-10 years in a senior leadership role.

- Must have worked in or with a foreign multinational pharmaceutical company (e.g., Pfizer, Zydus, Novartis, Sanofi, etc.).

- Strong understanding of international GMP norms, ICH guidelines, and regulatory requirements (USFDA, EMA, MHRA, WHO, etc.).

- Experience in managing complex quality operations across multiple plants or product categories.

- Proven ability to lead regulatory inspections and drive cross-functional compliance efforts.

- Excellent communication, leadership, and team-building skills.