The Head of Quality will ensure compliance with global regulatory standards (e.g., FDA, EMA, WHO GMP) while driving formulation innovation and product quality across the organization.
Key Responsibilities:
* Oversee all QA/QC activities, ensuring cGMP compliance and robust Quality Management Systems.
* Lead formulation development for new and existing pharmaceutical products.
* Manage tech transfer, process validation, and regulatory readiness.
* Direct internal audits, external inspections, and CAPA implementation.
* Build and mentor high-performing quality and R&D teams.
* Collaborate with Manufacturing, Regulatory, and Supply Chain for seamless operations.
Qualifications:
* 12+ years of experience in pharma manufacturing, with leadership in quality and formulation.
* Strong knowledge of cGMP, ICH guidelines, QbD, and regulatory requirements.
* Experience with regulatory inspections and international filings (e.g., ANDA, NDA).
What We Offer:
* Competitive compensation
* Leadership role with strategic impact
* Opportunity to drive quality and innovation in healthcare