At a Glance
- Tasks: Lead and manage GMP audits for biopharm and pharmaceutical facilities across EMEA.
- Company: Join GSK, a global leader in healthcare with a commitment to innovation.
- Benefits: Competitive salary, annual bonus, share-based incentives, and comprehensive benefits.
- Other info: Flexible location with travel opportunities and strong career growth potential.
- Why this job: Make a real impact on compliance and quality in the pharmaceutical industry.
- Qualifications: Degree in a relevant field and experience in GMP and compliance auditing.
The predicted salary is between 73050 - 121750 € per year.
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 regulatory and contractual commitments. The 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 (Supply Chain Directors, Site Directors, Site Quality Directors, VPs/Heads of support functions, R&D Quality).
- Perform audits of Global Supply Chain 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
Travel up to 40% of your time.
Qualifications
- Degree in a relevant Scientific, Technical or Engineering discipline.
- Relevant and specific experience 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 (planning, performing and reporting Quality and Regulatory Compliance audits).
- Working knowledge of Data Integrity and ALCOA+ principles within the Pharmaceutical industry.
- 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
- Italy: EUR 73,050 to EUR 121,750
- Spain: EUR 0 to EUR 0 (No listing)
- Belgium: EUR 78,750 to EUR 131,250
Benefits
Annual bonus and eligibility to participate in share-based long-term incentive program. Detailed benefits will be provided during recruitment.
Equal Opportunity Statement
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: ENGINEERINGUK
GSK is an exceptional employer that prioritises employee growth and development, offering a dynamic work culture where innovation and compliance are at the forefront of our operations. With opportunities to engage in meaningful audits across various highly regulated markets, employees benefit from competitive salaries, annual bonuses, and participation in share-based long-term incentive programmes, all while working in a collaborative environment that values diversity and inclusion.
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 current or former employees at GSK through LinkedIn or industry events. A friendly chat can give us insider info and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your GMP knowledge and compliance standards. We want to show that we’re not just qualified, but genuinely passionate about the role and the industry.
✨Tip Number 3
Practice those communication skills! Role-play common interview questions with a friend or in front of a mirror. We need to convey our expertise clearly and confidently, especially when discussing complex audits.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows we’re serious about joining the GSK team.
We think you need these skills to ace Audit Senior Lead (EMEA GMP Audit) in Worthing
Some tips for your application 🫡
Get to Know Us:Before you dive into your application, take a moment to explore our website and get familiar with StudySmarter. Understanding our mission and values will help you tailor your application to show how you fit in with our team.
Tailor Your CV:Make sure your CV is tailored specifically for the Audit Senior Lead role. Highlight your relevant experience in GMP audits and compliance, and don’t forget to showcase your strong communication skills – they’re key for this position!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background makes you the perfect fit. Be sure to mention any specific experiences that relate to the responsibilities outlined in the job description.
Proofread, Proofread, Proofread!:Before hitting that submit button, give your application a thorough proofread. Spelling mistakes or typos can make a bad impression, so take the time to ensure everything is polished and professional. We want to see your best self!
How to prepare for a job interview at ENGINEERINGUK
✨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 theory but can apply it in real-world scenarios.
✨Prepare for Stakeholder Engagement
Since this role involves managing complex stakeholder relationships, think about how you’ve successfully engaged with different levels of management in the past. Prepare some anecdotes that highlight your communication and influencing skills, as these will be crucial in your interviews.
✨Showcase Your Auditing Experience
Be ready to discuss your previous auditing experiences in detail. Highlight any unannounced or for-cause audits you've conducted, and be prepared to explain how you approached risk assessment and compliance issues. This will demonstrate your hands-on expertise in the field.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s audit processes and how they handle compliance risks. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career goals and values.
