CQA HEAD

Job Description : CQA HEAD CANADA Open to International candidates with 20+ years experience CQA Head to lead Quality Assurance operations for an Oncology manufacturing facility. The role demands strong expertise in regulatory compliance, audit management, and quality systems, ensuring the highest standards of GMP compliance and inspection readiness for global markets. ???? Key Responsibilities Quality Leadership & Compliance • Lead and manage end-to-end QA functions across plant operations • Ensure compliance with cGMP, USFDA, MHRA, PIC/S, EU-GMP guidelines • Establish and maintain a robust Quality Management System (QMS) Audit & Regulatory Management • Independently handle regulatory audits (USFDA, MHRA, PIC/S) • Manage regulatory inspections, observations, and CAPA closure • Lead regulatory query handling and response preparation Documentation & Systems • Oversee documentation control, data integrity, and compliance systems • Ensure adherence to ALCOA+ principles and regulatory expectations • Drive continuous improvement in quality systems Team Leadership & Coordination • Lead, mentor, and develop QA teams across functions • Ensure effective cross-functional coordination with Production, QC, RA, and Engineering • Strengthen audit readiness culture across the organization M.Pharm or equivalent qualification • Strong exposure to oncology / sterile formulations and OSD experience. • Deep knowledge of global regulatory requirements and GMP systems ? Key Skills & Competencies • Strong leadership and decision-making ability • Expertise in regulatory audits and compliance systems • Excellent communication and stakeholder management skills • Proven track record in handling critical inspections • Strategic thinking with operational execution capability

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