Managing and leading the QA Validation Oversight group who are responsible for the review and approval of Validation activities and documents in the Drug Substance Biopharmaceutical manufacturing facility.
• Reviews and performs final quality approval to Validation policies, plans, reports, protocols and deviations, ensuring that they are prepared and executed to the highest standards, complying with SOP and Regulatory requirements. Scope includes but is not limited to Equipment/Utility/Facility Qualification, Cleaning Validation & Steam Sterilisation Qualification, Computer System Validation, Assay Validation and Process Validation.
• Day to day management of the QA Validation Oversight team, planning and assigning responsibilities and tasks to Validations Specialists and measuring performance.
• Interviews, hires, onboards, and trains incoming personnel.
• Reviews validation protocol deviations, provides final quality approval and sign-off.
• Works collaboratively with key stakeholders in developing and reviewing validation strategies and plans.
• Plays a proactive role in developing and applying new approaches and processes to validation strategies and aligns globally on the future of the program(s).
• Regularly interacts with senior management to create a broad-based validation program.
• Applies complete functional knowledge and awareness of company goals and objectives.
• Counsels employees about work performance; conducts hiring and discharge interviews.
• Provide leadership and tactical support for regulatory, partner and internal audits for the QA Validation organization.
• Requires BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 9 years of experience, including at least 4 years in a validation and/or Quality Assurance organization.
• Previous team/people management experience essential.
• Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.
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