At a Glance
- Tasks: Lead GMP audits and ensure compliance in Biopharm and Pharmaceutical facilities.
- Company: Join GSK, a global leader in healthcare and pharmaceuticals.
- Benefits: Competitive salary, bonuses, and share-based incentives.
- Other info: Travel opportunities across Europe and dynamic career growth.
- Why this job: Make a real impact on quality and compliance in the healthcare industry.
- Qualifications: Degree in a relevant field and experience in Biopharm or Pharmaceuticals.
The predicted salary is between 73050 - 121750 € per year.
Site Name: UK - Hertfordshire - Ware, Belgium-Rixensart, Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Parma, Italy - Siena, UK - County Durham - Barnard Castle, UK - West Sussex - Worthing
Overview
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.
Position Details
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).
- 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.
- 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 & Travel
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 is required to sites across the network as part of the role; travel is anticipated to be 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, or Pharmaceutical industries.
- Subject matter expertise / knowledge of worldwide cGMPs, regulatory requirements, standards and Quality Management Systems for Steriles, Biopharm, Vaccines, or 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 or certification.
- Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, VPs and Heads of Support Functions).
Salary & Benefits
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
The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. Additionally, this position may offer an annual bonus and eligibility to participate in a share‑based long‑term incentive program.
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) employer: WISE Campaign
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 global locations, including Ware, Worthing, and Barnard Castle, employees benefit from competitive salaries, performance bonuses, and participation in long-term incentive programmes, all while contributing to the vital field of pharmaceuticals and biopharmaceuticals.
StudySmarter Expert Advice🤫
We think this is how you could land Audit Senior Lead (EMEA GMP Audit)
✨Tip Number 1
Network like a pro! Reach out to your connections in the Biopharm and Pharmaceutical sectors. 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 risks. 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. Mock interviews with friends can help you nail this down.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at GSK. Let’s get you that dream job!
We think you need these skills to ace Audit Senior Lead (EMEA GMP Audit)
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 proficiency in planning, performing, and reporting audits, so share specific examples that demonstrate your expertise.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at WISE Campaign
✨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 relationships, think about how you’ve successfully engaged with various stakeholders in the past. Prepare some anecdotes that highlight your communication and influencing skills, as these will be crucial during the interview.
✨Showcase Your Audit Experience
If you have previous auditing experience, be ready to discuss it in detail. Highlight any specific audits you've conducted, the challenges you faced, and how you overcame them. This will demonstrate your proficiency in planning, performing, and reporting audits.
✨Stay Updated on 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 informed will impress the interviewers and indicate that you’re committed to continuous learning.
