Alza Pharmaceuticals is seeking a highly experienced Quality Control (QC) Manager to lead and strengthen our QC operations. This is a senior leadership role designed for a results-driven professional with deep expertise in pharmaceutical quality systems and a specialized focus on Ophthalmology products.
Testing Oversight: Lead and manage analytical testing of raw materials, in-process samples, and finished products.
Validation & Qualification: Oversee method validation, process validation, and equipment qualification protocols.
Compliance Management: Ensure 100% adherence to GMP, GLP, and international regulatory standards.
Documentation: Review, approve, and maintain QC documentation, including SOPs, specifications, and technical reports.
OOS & CAPA: Investigate Out of Specification (OOS) results, deviations, and implement Corrective and Preventive Actions (CAPAs).
Regulatory Liaison: Act as the primary point of contact for DRAP and other regulatory authorities; support audits and regulatory submissions.
Team Leadership: Mentor and manage QC laboratory teams to maintain high performance and safety standards.
Education: B. Pharmacy / Pharm-D or MSc in Chemistry.
Experience: Minimum 10-15 years in Pharmaceutical Quality Control.
Specialization: Ophthalmology products experience is MANDATORY.
Industry Preference: Pharmaceutical Manufacturing.
Analytical Mastery: Strong command of techniques including HPLC, GC, UV, and FTIR.
Quality Systems: In-depth knowledge of Pharmaceutical Quality Systems (PQS).
Compliance: Excellent documentation skills and a rigorous approach to regulatory compliance.