CQA HEAD

Job Description : CQA HEAD PAN EUROPE To lead the Corporate Quality Assurance function, establishing uncompromised quality governance across the corporate office, manufacturing facilities and third-party contract sites (P2P). This senior leadership role is responsible for driving global compliance standards (EU GMP, Australia GMP, PIC/S), harmonizing cross-functional quality operations, and managing robust vendor qualification frameworks to fuel the company's international expansion. 1. Corporate Quality Governance & Global Compliance Design, approve, and implement corporate quality policies and standard operating procedures to meet top-tier global standards (EU GMP, Australia GMP, PIC/S, WHO-GMP). Establish robust corporate quality agreements and maintain cross-functional alignment among Production, Purchase, and Regulatory Affairs (RA). Maintain perpetual audit readiness across manufacturing and distribution units; lead regulatory inspections, handle audit responses, and ensure strict CAPA implementation. 2. End-to-End Specification & Document Management Oversee the lifecycle, version control, and approval of Master Specification Files for Raw Materials (APIs, Excipients), Packaging Materials (Primary, Secondary, Tertiary), and Finished Products. Ensure all technical specifications, drug-packaging compatibility parameters (GSM, Burst Strength, WVTR), and testing protocols strictly comply with international pharmacopeia (USP, BP, EP, IP) and ICH guidelines (Q3C, Q6A). 3. Strategic Factory & Corporate Liaison (SPOC) Serve as the primary, high-level corporate liaison (SPOC) Pune Corporate Office and the manufacturing sites. Resolve complex factory-level quality issues and raw/packaging material non-conformances by aligning them with corporate directives and global compliance standards. 4. Vendor Qualification & Third-Party (P2P) Management Formulate and lead the vendor qualification framework, executing rigorous on-site audits for raw material suppliers, packaging vendors, and third-party loan license/contract manufacturers (P2P). Partner with the Procurement/Purchase Department to evaluate supplier quality capabilities, establish clear quality standards, and monitor vendor performance metrics. Key Requirements & Technical Competencies Education & Experience: B.Pharm / M.Pharm with 25+ years of progressive experience in Pharmaceutical/Veterinary QA, with a proven track record in a senior corporate or multi-site management role. Audit Exposure: Direct experience facing or managing audits from stringent regulatory bodies such as EU GMP, MHRA, WHO-GMP, or USFDA. Pharmacopeial Expertise: Mastery over pharmacopeial monographs (IP, USP, BP, EP), analytical testing frameworks (HPLC, GC, UV), and international regulations (ICH, GMP, GDP). Strategic Capabilities: Strong leadership skills to drive quality culture, with the flexibility to travel to third-party manufacturing (P2P) sites and suppliers as required. Communication: Exceptional verbal and written business communication skills to interact with regulatory bodies, vendors, and top management.

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