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- Tasks: Lead global GxP audit and inspection readiness programs to ensure compliance and quality.
- Company: Join Mundipharma, a global healthcare leader dedicated to patient safety and innovative treatments.
- Benefits: Enjoy learning opportunities, a collaborative environment, and a focus on diversity and inclusion.
- Why this job: Make a real impact in healthcare by ensuring the highest standards of quality and compliance.
- Qualifications: 10+ years in GxP auditing with strong strategic thinking and leadership skills.
- Other info: Be part of a dynamic team that values growth, integrity, and patient-centricity.
The predicted salary is between 48000 - 72000 ÂŁ per year.
Location: Cambridge
Department: Quality
Job type: Permanent
Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.
The Team
The role will strategically lead and coordinate the global GxP audit and inspection readiness program, ensuring sustained compliance with international regulatory standards across all Good Practice domains. You will drive proactive inspection preparedness, orchestrate cross‑functional audit activities, and embed a culture of continuous improvement within quality systems. This role ensures alignment of global teams on inspection strategy, robust documentation and data integrity, and operational excellence through risk‑based compliance oversight and regulatory intelligence.
Role and Responsibilities
- Strategic Leadership
- 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.
- Audit Program Management
- 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.
- Inspection Readiness
- 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.
- Governance and Reporting
- 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 who demonstrate a growth mindset and make decisions based on the patient.
- Provide coaching, development, and performance management to the team.
- Stakeholder Engagement
- Collaborate effectively with Quality, Safety, Regulatory Affairs, R&D, Manufacturing and other functions to ensure proactive inspection readiness.
- Be an active member of the Quality Leadership Team representing audit and inspections.
- Represent the company in regulatory interactions and industry forums.
Qualifications
- Education
- Bachelor’s or advanced degree in life sciences, pharmacy, or related field.
- Certifications or Designations
- Potential QP or QPPV experience.
- Experience
- Minimum 10 years of experience in GxP auditing and regulatory inspections.
- Deep understanding of international GxP regulatory requirements and quality systems.
- Experience interacting with regulatory authorities during inspections.
- Knowledge and Skills
- 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.
What we offer in return
- Opportunities for learning & development through our varied programme.
- Collaborative, inclusive work environment.
Diversity and inclusion
Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.
About Mundipharma
Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient‑Centricity, are at the heart of everything they do.
For more information visit www.mundipharma.com.
GXP Audit and Inspection Director in Cambridge employer: Mundipharma
Contact Detail:
Mundipharma Recruiting 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 your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We can’t stress enough how important it is to make those personal connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We recommend practising common interview questions and even role-playing with a friend to boost your confidence.
✨Tip Number 3
Showcase your expertise during interviews! Bring examples of your past work, especially those that highlight your strategic leadership and audit management skills. We want to see how you can bring value to the team at Mundipharma.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. And remember, apply through our website for the best chance at landing that dream job!
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 strategic thinking and risk management skills!
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 healthcare. Mention specific examples of how you've led audit programs or managed inspection readiness in the past.
Showcase Your Leadership Skills: Since this role involves building and managing a high-performing global audit team, be sure to highlight your leadership experience. Talk about how you've developed teams and fostered a culture of continuous improvement in previous roles.
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 receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at Mundipharma
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of Good Practice (GxP) regulations. Understand the latest international standards and how they apply to the role. This will not only show your expertise but also demonstrate your commitment to compliance and patient safety.
✨Prepare for Scenario-Based Questions
Expect questions that assess your strategic thinking and risk management skills. Prepare examples from your past experiences where you've successfully led audit programs or managed inspection readiness. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Showcase Your Leadership Skills
As a potential leader in this role, be ready to discuss how you've built and managed high-performing teams. Highlight your coaching and development strategies, and how you've fostered a culture of continuous improvement within quality systems.
✨Engage with Stakeholders
Demonstrate your ability to collaborate across functions by discussing past experiences where you've worked with Quality, Safety, Regulatory Affairs, and other departments. Show that you understand the importance of stakeholder engagement in ensuring proactive inspection readiness.
