At a Glance
- Tasks: Lead global GxP audit strategies and ensure compliance with regulatory standards.
- Company: Mundipharma, a leader in quality and patient safety.
- Benefits: Learning opportunities, inclusive culture, and focus on diversity.
- Other info: Join a dynamic team and collaborate across various functions.
- Why this job: Make a significant impact on patient safety and quality standards globally.
- Qualifications: 10+ years in GxP auditing with strong leadership skills.
The predicted salary is between 80000 - 100000 £ per year.
Location: Cambridge
Department: Quality
Job type: Permanent
At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety.
Responsibilities
- Develop and execute a global GxP audit and inspection strategy aligned with company objectives and the Quality Management System.
- Lead cross‑functional inspection readiness programs, including mock inspections.
- Serve as the primary point of contact for regulatory inspections.
- Oversee internal and external audit programs across all GxP areas, including vendor and supplier audits.
- Ensure audit schedules are risk‑based and cover all relevant GxP domains.
- Coordinate pre‑inspection activities such as training, documentation review, and facility walkthroughs.
- Lead inspection response teams and manage post‑inspection responses, remediation, and CAPA execution.
- Provide regular updates to senior leadership on audit outcomes, inspection risks, and compliance trends.
- Maintain metrics and dashboards to monitor audit performance and inspection readiness.
- Build and manage a high‑performing global audit team, including coaching, development, and performance management.
- Collaborate effectively with Quality, Safety, Regulatory Affairs, R&D, Manufacturing and other functions to ensure proactive inspection readiness.
- Act as an active member of the Quality Leadership Team and represent the company in regulatory interactions and industry forums.
Qualifications
- Bachelor’s or advanced degree in life sciences, pharmacy, or related field.
- Potential QP or QPPV experience.
- Minimum 10 years of experience in GxP auditing and regulatory inspections.
- Proven leadership in matrix‑managing global audit programs.
- Deep understanding of international GxP regulatory requirements and quality systems.
- Experience interacting with regulatory authorities during inspections.
- Strong strategic thinking and risk management skills.
- Excellent communication and stakeholder management.
- Ability to influence across functions and geographies.
- High attention to detail and analytical capability.
- Leadership and team development skills.
Benefits
- Opportunities for learning & development through our varied programme.
- Collaborative, inclusive work environment.
- Diversity and inclusion.
GXP Audit and Inspection Director in Cambridge employer: Mundipharma International Technical Operations
At Mundipharma, we pride ourselves on fostering a collaborative and inclusive work environment that prioritises employee growth and development. As a GxP Audit and Inspection Director in Cambridge, you will have the opportunity to lead a high-performing global audit team while contributing to our commitment to quality and patient safety. With a strong focus on diversity and continuous learning, we offer a rewarding career path where your expertise will be valued and your contributions will make a meaningful impact.
Contact Details:
Mundipharma International Technical Operations Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land GXP Audit and Inspection Director in Cambridge
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant events. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We recommend practising common interview questions and tailoring your answers to highlight your GxP expertise. Show them you’re the perfect fit!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can leave a lasting impression. We suggest reiterating your enthusiasm for the role and mentioning something specific from the conversation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace GXP Audit and Inspection Director in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GxP Audit and Inspection Director role. Highlight your relevant experience in GxP auditing and regulatory inspections, and don’t forget to showcase your leadership skills and strategic thinking.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role at Mundipharma. Mention specific examples of how you've led audit programs or managed inspection readiness that align with the job description.
Showcase Your Achievements:When filling out your application, be sure to include quantifiable achievements. Whether it’s improving audit performance metrics or successfully leading a cross-functional team, numbers speak volumes and can set you apart from other candidates.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application directly and ensures you don’t miss any important updates about your application status!
How to prepare for a job interview at Mundipharma International Technical Operations
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of GxP regulations and standards. Familiarise yourself with the latest updates in the industry, as well as any specific guidelines relevant to Mundipharma. This will show that you're not just qualified but genuinely interested in the role.
✨Prepare for Scenario-Based Questions
Expect to be asked about how you've handled past audit situations or regulatory inspections. Prepare specific examples that highlight your strategic thinking, risk management skills, and leadership abilities. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Showcase Your Leadership Style
As a GxP Audit and Inspection Director, you'll need to lead a team effectively. Be ready to discuss your leadership style and how you develop high-performing teams. Share examples of how you've coached team members or managed cross-functional collaborations in the past.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company's current challenges in GxP compliance or their vision for the audit team. This shows your enthusiasm for the role and helps you gauge if the company is the right fit for you.
