Quality Head

Job Description : Head -Quality /Sr Vice President -Injectable /Biopharma Responsibilities Lead the Team with Accountability for Quality Assurance & Compliance Programs ensuring Quality is a Strategic Differentiator of the Business. Responsible for keeping Management Team informed of Quality Status of Products & Manufacturing Site. Represent the Quality Division before regulatory authorities related to product & Quality Issues Ensure understanding of the external Regulatory Competitive Environment Globally to Adapt Product Quality Strategy Oversee the Divisions QA Metrics (KPIs) to track Quality &drive overall improvements in Submissions Activities Manage & Support the Systems required to Perform the Core site Activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective & Preventative Actions (CAPAs), investigations, Change Control, Validations, Material Disposition, Complaints, internal / external Audit/inspections & Customer enquiries/Questionnaires Perform Gap Assessments & lead the site implementation of Corporate Quality policies. Provide oversight to the Review & Approval of GxP Documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, Validation Protocols & all other Quality Management System (QMS) Documentation Oversees all Aspects of QA Operations within the facility, including but not limited to executed Batch record review, on the floor QA Support, Material release, Deviation investigations, Change Controls, customer quality support and SOP & master batch record review. Implement Robust Business Processes to Support the Right First Time execution of Batch records, ensure timely disposition of Raw Materials, Drug Substance and Drug Product & Oversee execution of Robust investigation leading to effective Corrective & Preventative Actions. Develop Directs & Maintains Quality Systems in Support of Manufacturing in a Manner Consistent with Global Quality Systems requirements, Corporate Standards & Current Regulatory requirements Ø Facilities the Development, implementation & Maintenance of Procedures & Policies to Comply with FDA, EU & ICH requirements Applicable to Site’s Needs MSc/PhD with about 20-25 Years of Experience in any Biopharma Organization

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