Senior Quality Assurance Manager
2 weeks ago
About the Role
We are seeking a highly skilled Team Lead TA Quality to join our team at GSK. As a Team Lead TA Quality, you will be responsible for leading a team of Quality Business Partners that deliver independent quality expert support to stakeholders. You will be a member of the QBP Therapeutic Area LT and provide input into the quality strategy of this function.
Key Responsibilities
- Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements, and industry best practices.
- Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis.
- Provides input into global audit plan based on identified signals/trends/risks/gaps.
- Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and QuRE management.
- Drive Quality by Design implementation on an asset level.
- Supports the preparation, execution and close out of health authority inspections.
- Demonstrates implementation of quality strategy to health authorities.
- Participate/ provides expertise in Due Diligence (in-licensing activities) as applicable.
Requirements
- Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
- Experience in pharmaceutical industry and/or quality assurance.
- Demonstrated ability to work in an international environment leading global quality team; with previous supervisory/management experience.
- Knowledge of principles and concepts of quality assurance, (quality) risk management, and quality by design.
- Knowledge of GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational, and planning skills.
What We Offer
At GSK, we offer a comprehensive benefits program, including competitive compensation, comprehensive health insurance, retirement savings, and paid time off. We also offer opportunities for professional development and growth within the company.
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