At a Glance
- Tasks: Lead GMP audits and ensure compliance in Biopharm and Pharmaceutical facilities.
- Company: Join GSK, a global leader in healthcare innovation.
- Benefits: Competitive salary, travel opportunities, and a diverse work environment.
- Other info: Exciting career growth with opportunities to travel across Europe.
- Why this job: Make a real impact on quality and compliance in the biopharmaceutical industry.
- Qualifications: Degree in a relevant field and experience in Steriles/Biopharm/Vaccines.
The predicted salary is between 73050 - 121750 € per year.
Are you an experienced Biopharm, Vaccines, or Pharmaceutical professional looking for an exciting opportunity to leverage your expertise to support GSK Senior Management in the identification, prioritisation, and monitoring of quality, compliance, and technical risks? If so, this role within our Quality organisation could be a great opportunity for you.
The purpose of the Audit Senior Lead role is to perform and manage GMP (Good Manufacturing Practice) and Compliance audits of Biopharm, Vaccines, and Pharmaceutical facilities that supply highly regulated markets. You will be responsible for evaluating the compliance of GSK Global Supply Chain (internal and external) facilities with GMP, applicable policies and procedures, and regulatory and contractual commitments. Your remit will include audits of Global Supply Chain internal and external networks manufacturing facilities and operations, Local Operating Companies (LOCs), R&D and Logistics Service Providers (LSPs). In this role, you will also provide sterile manufacturing subject matter expertise for the GSK Global Supply Chain EMEA auditing team. Strong communication and influencing skills will be key to success.
Key Responsibilities
- Manage complex stakeholder engagement for audits across the network (which may include Supply Chain Directors, Site Directors, Site Quality Directors, VPs/Heads of support functions, and Research & Development Quality).
- Performing audits of Global Supply Chain (GSC) sites, LOCs, and external manufacturing sites (including R&D), LSPs and facilities supplying EMEA and other highly regulated markets.
- Perform unannounced audits.
- Perform for‑cause audits based on regulatory actions or identified risk.
- Perform process, quality system‑specific, and targeted audits.
- Perform audits against risk mitigation plans or regulatory citation commitments.
- Produce clear, concise, and objective audit reports to ensure senior management is appraised of identified risks and that appropriate corrective action plans are implemented.
Location
This role can be based at any of the following manufacturing sites: Ware, Worthing, Barnard Castle (UK), Siena, Parma (Italy), Wavre, Rixensart (Belgium) or Tres Cantos (Spain).
Travel
Please note that the successful applicant will need to travel to sites across the network as part of the role. We anticipate travel will be approximately up to 40% of your time.
Basic Qualifications
- Degree in a relevant Scientific, Technical or Engineering discipline.
- Relevant and specific experience obtained from working in Steriles/ Biopharm / Vaccines / Pharmaceutical industries.
- Subject matter expertise / knowledge of worldwide cGMPs, regulatory requirements, standards and Quality Management Systems for Steriles/ Biopharm / Vaccines / Pharmaceutical Manufacturing and Packing.
- Experience in identifying and/or managing complex Quality and Compliance risks and issues.
Preferred Qualifications
- Previous auditing experience preferred (e.g. proficiency and experience in planning, performing and reporting Quality and Regulatory Compliance audits).
- Working knowledge and ability in evaluation of Data Integrity and ALCOA+ principles within the Pharmaceutical industry.
- Increasing knowledge of AI tools, applications and ways of working in the Pharmaceutical industry.
- Auditor formal accreditation/certification.
- Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, VPs and Heads of Support Functions).
Salary
Italian Salary Range: EUR 73,050 to EUR 121,750
Belgium Salary Range: EUR 78,750 to EUR 131,250
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Audit Senior Lead (EMEA GMP Audit) in Worthing employer: GlaxoSmithKline
GSK is an exceptional employer that prioritises employee growth and development within a collaborative and inclusive work culture. With opportunities to engage in meaningful audits across diverse global supply chains, employees benefit from a dynamic environment that fosters innovation and compliance excellence. The company's commitment to quality and regulatory standards, combined with its presence in multiple European locations, offers a unique chance to make a significant impact in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Audit Senior Lead (EMEA GMP Audit) in Worthing
✨Tip Number 1
Network like a pro! Reach out to your connections in the Biopharm and Pharmaceutical sectors. Attend industry events or webinars where you can meet potential employers and showcase your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and compliance standards. Be ready to discuss specific examples from your past experiences that demonstrate your skills in managing quality and compliance risks.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds!
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge. Plus, it’s super easy to navigate!
We think you need these skills to ace Audit Senior Lead (EMEA GMP Audit) in Worthing
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in Biopharm, Vaccines, or Pharmaceuticals. We want to see how your skills align with the key responsibilities of the Audit Senior Lead role, so don’t hold back on showcasing relevant projects and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality and compliance in the pharmaceutical industry. We love seeing candidates who can communicate their enthusiasm and fit for the role, so let your personality come through.
Showcase Your Stakeholder Management Skills:Since this role involves managing complex stakeholder engagement, make sure to highlight any relevant experiences where you've successfully navigated relationships with senior management or cross-functional teams. We want to know how you influence and communicate effectively!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of success. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come through our own platform!
How to prepare for a job interview at GlaxoSmithKline
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and relevant regulatory requirements. Be prepared to discuss how these apply to the Biopharm, Vaccines, and Pharmaceutical industries, as this will show your expertise and readiness for the role.
✨Showcase Your Audit Experience
Highlight any previous auditing experience you have, especially in planning, performing, and reporting audits. Be ready to share specific examples of how you've identified and managed quality and compliance risks in past roles, as this will demonstrate your capability to handle the responsibilities of the Audit Senior Lead.
✨Engage with Stakeholders
Since managing complex stakeholder engagement is key, think about how you can effectively communicate and influence various stakeholders. Prepare examples of how you've successfully navigated challenging conversations or built relationships with senior management in previous positions.
✨Prepare for Travel Discussions
As travel is a significant part of this role, be ready to discuss your flexibility and willingness to travel. Consider how you can manage your time effectively while balancing site visits and audit responsibilities, and be prepared to share your strategies for staying organised during travel.
