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Quality Assurance Director
2 months ago
We are seeking a highly skilled Quality Assurance Director to join our team at GlaxoSmithKline. As a key member of our R&D Quality and Risk Management function, you will be responsible for providing strategic, expert advice and consultation on R&D quality with impact across the Good Practices.
Key Responsibilities- Quality Business Partner: Serve as the quality business partner for assigned GSK R&D functions, programs, and/or Third Parties supporting Health Care technologies, Invitro devices (IVD's), and lab methods.
- Quality Expertise: Work closely with business and/or Third Party teams to provide expert quality information, manage identified issues, and support continuous improvement particularly in scope of Health Care Technologies, IVDR, and clinical lab regulations.
- Audit and Inspection Support: Collaborate with the Audit, Inspection, Risk, and Issue Management teams within R&D Quality and Risk Management function on all internal quality audits, regulatory agency inspections, risk assessments, issue, and CAPA activities.
- Regulatory Compliance: Support evaluation of R&D to emerging Health Care Technologies and IVD regulations in our portfolio.
- Issue Identification and Resolution: Support issue identification, reporting, root cause analysis, and CAPA development.
- Quality Management: Evaluate and/or review standard operating procedures and perform other activities in support of an integrated, cross-functional QMS.
- Leadership and Communication: Provide matrix management and leadership to cross-functional teams. Foster a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties.
- Quality Consultation: Responsible for quality consultation for the assigned function, program, and/or Third Party.
- Quality Strategy: Define, implement, and monitor the quality narrative/quality brief and report any critical risk.
- Due Diligence and Mergers and Acquisitions: Support due diligence and Merger & Acquisition activities.
- Quality Issue Communication: Ensure rapid communication of quality issues and risks, including potential misconduct, to appropriate leaders and colleagues.
- Investigations and Special Assignments: Support the investigations of potential serious breaches and critical issues. Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.
- Knowledge Sharing: Share key learnings to drive simplification and replicate best practices to drive quality into the business.
- Education: Bachelor's Degree in a Scientific Discipline.
- Experience: Minimum 8 years in drug development, regulatory compliance, or quality management. Minimum 3 years in clinical, medical, pharmacovigilance, or regulatory quality.
- Regulatory Knowledge: Demonstrated knowledge of GLP, GCP, GVP, and regulatory requirements.
