Senior Manager, Quality Audit

Site Name: Dresden - Office, France - Saint-Amand-les-Eaux, Hungary Gödöllő, Italy - Siena, Marburg - Office, UK - London - Brentford, Belgium-Rixensart
Posted Date: Jun 3 2021

Are you energized by a highly technical quality assurance role that allows you to accelerate compliance and mitigate risk in a state-of-the-art manufacturing environment? If so, this Internal Quality Audit Manager role could be an exciting opportunity to explore.

As an Internal Quality Audit Manager, you will be responsible for ensuring overall quality standards are met for products. You'll establish and maintain quality standards of existing products and services, also developing programs to focus employees on quality improvement.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

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.

• 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.
• 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 & Third Parties commercial Audit Team and R&D 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.
• Lead strategic Regulatory Inspection Management activities, i.e. assessments in preparation of strategic inspections, Health Authorities commitments verification, qualification audits and support due diligence assessments as needed.
• Serve as a business partner to enhance GSK's risk management capabilities and actively identify and share good practices and improvement opportunities.
• Remain current with industry trends and changes in the regulatory and GXP standards. Participate to external forums and conferences to ensure external knowledge on GXP is brought in GSK.
• Coach associates on the correct interpretation and implementation of regulatory requirements.
• Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures.
• Sit in internal forums as the GXP expert providing recommendation for new approaches in the GXP environment with the purpose of providing advice on how to ensure continued compliance to regulations while still supporting the simplification and advancement of the use of new technology.
• Proactively look for continuous improvement of audit system process and actively engage to have improvements implemented by means of technical knowledge and influencing/communication skills
• Identify opportunities to build skills for current and future needs and share learnings with the audit team. Mentor auditor colleagues as required and support qualification of new auditors.

Why you? Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Experience with quality management systems and Current Good Manufacturing Practices (cGMP) is essential.
• Bachelor's degree in Biology, Chemistry, Pharmacy or Engineering to investigate and understand various processes (both technical and regulatory compliance) across the Vaccines network and discern if risks or issues exist.
• At least 10 years of experience in a pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC and project management roles.

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

• Strong knowledge of regulatory and GXP regulations (European, US, China, WHO, and industry publications such as GAMP, ICH, PIC/S.)
• Demonstrated leadership and experience in influencing improvement activity to ensure implementation of appropriate CAPAs.
• Qualified/Certified auditor is a plus.
• GCLP knowledge is a plus but no essential
• Knowledge of European language is a plus.
• Broad problem solving with limited information available to make strategic decisions and interpret.
• Diverse problem solving with limited information available to make decisions and interpretations.
• Experience with resolving non-routine similar issues.
• Experience with selects best option and follow precedence - Problem solving education and fully competent to root cause
• Experience with identifying problems and may propose solutions within remit
• Experience with operating in a well-defined environment, escalates issues/problems.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

*LI-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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