Quality Assurance Manager
4 weeks ago
Quality Business Partner Job Description
This role focuses on driving quality into business by providing expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility. As a Quality Business Partner, you will serve as the quality advocate and change agent for your given area of responsibility, working closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
Main Responsibilities:
- Provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility.
- Serve as the Quality Business Partner for assigned GSK R&D functions, programs, and/or Third Parties.
- Work closely with business to provide expert quality information, manage identified issues, and support continuous improvement.
- Provide matrix management and leadership to cross-functional teams.
- Collaborate with the Audit, Inspection, Risk, and Issue Management team within R&D Quality and Risk Management on all internal quality audits, regulatory agency inspections, risk assessments, issue, and CAPA activities.
- Lead inspection readiness activities and support regulatory inspections.
- Support issues identification, reporting, root cause analysis, and CAPA development.
- Evaluate and review standard operating procedures and other activities in support of an integrated, cross-functional Quality Management System.
- Influence senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties.
Requirements:
- Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge.
- Experience in drug development, regulatory compliance, or quality management.
- Experience in clinical, medical, pharmacovigilance, or regulatory quality.
- Expert knowledge of GLP, GCP, GVP, and regulatory requirements.
- Ability to lead cross-functional project and/or matrix teams to an aligned strategy.
- Broad working knowledge/expertise in principles and concepts of quality by design, quality briefs, and risk management.
- Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
- Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
- Ability to adapt to changing direction and needs of the business.
- Effective communication/negotiation skills and customer management skills.
About GSK:
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology). We believe in an agile working culture for all our roles and are an Equal Opportunity Employer, committed to diversity and inclusion.
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