At a Glance
- Tasks: Lead GMP audits and ensure compliance in Biopharm and Pharmaceutical facilities.
- Company: Join GSK, a leader in the biopharmaceutical industry with a commitment to quality.
- Benefits: Competitive salary, annual bonus, share-based incentives, and comprehensive benefits package.
- Other info: Travel up to 40% across various European sites for dynamic auditing experiences.
- Why this job: Make a real impact on global health by ensuring high-quality standards in manufacturing.
- Qualifications: Degree in a relevant field and experience in Biopharm or Pharmaceuticals required.
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 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 (Supply Chain Directors, Site Directors, Site Quality Directors, VPs/Heads of support functions, and Research & Development Quality).
- Perform 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.
- Conduct unannounced audits.
- Conduct for‑cause audits based on regulatory actions or identified risk.
- Conduct process, quality system‑specific, and targeted audits.
- Audit 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
The successful applicant will need to travel to sites across the network. Approximately up to 40% of your time will be spent traveling.
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 Ranges
Italian Salary Range: EUR 73,050 to EUR 121,750
Spanish Salary Range: EUR 0 to EUR 0
Belgium Salary Range: EUR 78,750 to EUR 131,250
Benefits
In addition, this position may offer an annual bonus and eligibility to participate in a share‑based long‑term incentive program, dependent on the level of the role. Detailed information on the total benefits package will be supplied during the recruitment process.
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 Barnard Castle employer: Gsk
GSK is an exceptional employer that prioritises employee growth and development within a collaborative and inclusive work culture. With opportunities to engage in meaningful work across various locations, including Ware and Worthing in the UK, GSK offers competitive benefits, including annual bonuses and share-based incentives, ensuring that employees are rewarded for their contributions while working in a dynamic and innovative environment.
StudySmarter Expert Advice🤫
We think this is how you could land Audit Senior Lead (EMEA GMP Audit) in Barnard Castle
✨Tip Number 1
Network like a pro! Reach out to your connections in the Biopharm and Pharmaceutical industries. Attend industry events or webinars, and don’t be shy about introducing yourself to potential employers. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and compliance standards. Be ready to discuss your previous auditing experiences and how you’ve tackled complex quality issues. Show them you’re not just a candidate, but the candidate they need!
✨Tip Number 3
Don’t forget to showcase your communication skills! In this role, you’ll be engaging with various stakeholders, so practice articulating your thoughts clearly and confidently. Use examples from your past to demonstrate how you’ve influenced decisions in your previous roles.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, get your CV polished and hit that apply button!
We think you need these skills to ace Audit Senior Lead (EMEA GMP Audit) in Barnard Castle
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 Audit Senior Lead role, so don’t be shy about 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.
Showcase Your Auditing Experience:If you’ve got previous auditing experience, make sure to highlight it! We’re looking for someone who can manage complex audits and stakeholder engagement, so share specific examples of your past work that demonstrate these skills.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Gsk
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and relevant regulatory requirements. Being able to discuss specific examples from your experience will show that you’re not just familiar with the concepts, but that you can apply them in real-world scenarios.
✨Prepare for Stakeholder Engagement
Since this role involves managing complex stakeholder engagement, think about how you’ve successfully navigated similar situations in the past. Prepare anecdotes that highlight your communication and influencing skills, as these will be crucial in your discussions during the interview.
✨Showcase Your Audit Experience
If you have previous auditing experience, be ready to discuss it in detail. Highlight specific audits you've conducted, the challenges you faced, and how you ensured compliance. This will demonstrate your capability and confidence in handling the responsibilities of the Audit Senior Lead role.
✨Stay Current with Industry Trends
Familiarise yourself with the latest trends in the pharmaceutical industry, especially regarding AI tools and data integrity principles. Showing that you’re proactive about staying updated will impress the interviewers and indicate that you’re committed to continuous improvement in your field.
