Senior Manager, Team Leader Quality Audit
We are looking for a R&D profile with a significant knowledge in clinical and medical affairs.
The primary responsibility of the Senior Manager - Team Leader, Quality Audit is to:
- Carry out an independent quality oversight across the Vaccines organization by performing internal and external audits in order to assess:
• Sustainability and compliance of our operations with GXP expectations.
• Risk management/escalation and governance processes.
- Identify and communicate to the management any issues that impact data integrity and accuracy, product quality, safety or efficacy, regulatory compliance or business continuity.
- Support continuous improvement of audit system and processes.
- Manage a team of auditors related to a business specific area.
- Support and embed a 'One Audit' culture through audits and assessments at GSK Vaccines and Third Parties, i.e. Strategic Global Suppliers, Contractors, Licensees, Alliance Partners & future business partners.
- Manage a team of auditors including objective setting, developing/coaching team members and support on day-to-day activities as needed.
- Lead and participate in audit/assessment engagements. Activities include, but are not limited to team coordination, monitoring of progress towards plan, liaison with auditee, scope definition and overall assessment of internal controls for the applicable process(es) / risk(s).
- Whether leading or participating on audits, provide leadership to ensure that audits deliver fit-for-purpose, risk based assurance that is responsive to the current business and risk environment. Collaborate across Internal & TPO Audit Team to ensure holistic consideration of risk and business context. Ensure that audits are delivered to the highest level of quality, and are conducted efficiently, maximizing team productivity.
- Make sure that CAPA plan is defined to properly address the audit findings, i.e. achieving or maintaining the "in use" status of the quality standards taking into account quality/compliance requirements and lean principles.
- Support the strategic Regulatory Inspection Management activities, i.e. assessments in preparation of strategic inspections, Health Authorities commitments verification.
- Serve as a business partner to enhance GSK's risk management capabilities and actively identify and share good practices and improvement opportunities.
- Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
- Support development and continuous improvement of audit system and processes.
- Develop and maintain collaborative relationships with Quality & Business partners for a specific area ; review the audit reports related to this area to ensure consistency.
- Manage selection and quality oversight of Audit Service Providers to help audit capacity and flexibility.
• University degree in Biology, Chemistry, Pharmacy or engineering
• with experience in (bio)pharmaceutical quality operations, manufacturing and R&D
• with awareness of GXP and international standards
• exposure to Health Authorities is a plus
• R&D experience with significant knowledge in clinical and medical affairs
• At least 10 years of experience in a pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC or project management roles.
• Experience in Clinical, Medical or Regulatory Affairs is a significant plus.
• Strong knowledge of regulatory and GXP regulations (European, US, Japanese, WH0 ...).
• Demonstrated leadership ability and experience in influencing improvement activity to ensure implementation of appropriate CAPAs.
• Qualified/Certified auditor is a plus.
• People management is a plus
• Excellent English writing skills.
• Communications skills to ensure issues, risks and opportunities are well understood and that effective actions are put in place.
• Strong problem solving and analytical skills.
• Customer focused; ability to understand requirements of local sites.
• In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation).
• Good understanding of vaccines or similar biologics manufacturing and controls (primary and secondary operations) as well as raw material manufacturing technologies.
• Good understanding of R&D environment and processes is a significant plus.
• Ability to adapt, work under uncertainty and accommodate flexible work demands.
• Global perspective; cultural sensitivity.
• Self-motivated; Sense of urgency.
• Travel: 30-40%.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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