At a Glance
- Tasks: Lead quality management and compliance in pharmacovigilance, driving strategic initiatives and investigations.
- Company: Bristol Myers Squibb, a leader in transforming patients' lives through science.
- Benefits: Competitive salary, travel opportunities, and a commitment to diversity and inclusion.
- Other info: Join a dynamic team focused on continuous improvement and career growth.
- Why this job: Make a real impact on patient safety and quality in a global organisation.
- Qualifications: 10+ years in pharma, with expertise in GVP deviation and inspection management.
The predicted salary is between 70000 - 90000 £ per year.
About the Role
At Bristol Myers Squibb, we are committed to transforming patients’ lives through science. Our Patient Safety Quality Management (SQM) team sits at the heart of that mission — ensuring our pharmacovigilance systems are world‑class, inspection‑ready, and continuously improving. We are looking for a seasoned quality and compliance leader to drive strategic GVP deviation management, CAPA oversight, and quality risk management across a global, matrixed organization.
What You Will Do
- Lead the strategic investigation and closure of high‑impact GVP deviations, shaping remediation priorities and organizational risk management at a senior level.
- Drive enterprise‑wide CAPA management and quality risk initiatives, ensuring full alignment with global regulatory requirements.
- Deliver advanced root cause analyses and trend intelligence, translating complex data into persuasive recommendations for senior leadership.
- Maintain and evolve QMS documentation, setting policy standards for deviation management, management notification, and CAPA processes.
- Build and champion cross‑functional partnerships across R&D and BMS, embedding a consistent culture of quality and continuous improvement.
- Serve as the internal authority for global Deviations and CAPA networks, influencing enterprise IT systems and processes to meet GVP requirements.
- Lead the Pharmacovigilance Safety Quality Forum, reporting quality events, audit CAPAs, and risk management findings to senior Patient Safety leadership.
- Oversee the accuracy and strategic use of deviation and CAPA data within the Pharmacovigilance System Master File (PSMF).
- Monitor external intelligence — regulations, guidance documents, Health Authority inspection reports — ensuring risks are reviewed, escalated, and actioned appropriately.
- Design and deliver impactful training programs that sharpen team expertise and maintain audit and inspection readiness.
- Support GVP inspections in close collaboration with the PV Quality function.
Education and Experience
- University degree in health or life sciences, or a nursing qualification (preferred).
- 10+ years in the pharmaceutical industry, with at least 5 years in Pharmacovigilance or a related discipline (Regulatory Affairs, Clinical, Medical Information).
- Minimum 3 years of hands‑on experience in GVP Deviation and/or Inspection Management.
- Proven track record leading quality management, compliance, or audit functions within pharma.
- Demonstrated success managing cross‑functional teams and delivering complex strategic projects.
Skills and Capabilities
- Expert‑level proficiency in deviation investigation and CAPA development, including root cause analysis methodologies (Five Whys, Is/Is Not, cause‑and‑effect analysis).
- Exceptional communication skills — able to distil complex compliance data into clear, compelling narratives for senior stakeholders.
- Strong influencing and negotiation abilities, with sound judgment on escalation and conflict resolution.
- Highly organized with the ability to manage multiple high‑priority workstreams under stringent timelines, including inspection readiness activities.
- Proficient in pharmacovigilance tools, corporate QMS platforms, document management systems (SharePoint), and Microsoft Office Suite.
- Deep knowledge of global pharmacovigilance regulations and the ability to serve as an internal subject matter authority.
- Proactive mindset for identifying process improvement opportunities and driving efficiency across the Patient Safety organization.
Additional Information
- Travel: Approximately 10–25%, including overnight travel.
Equal Employment Opportunity Statement
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Bristol Myers Squibb is Disability Confident – Employer. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Senior Manager, PV Process Quality Lead in Uxbridge employer: Bristol Myers Squibb EU Policy
At Bristol Myers Squibb, we pride ourselves on being an exceptional employer dedicated to transforming patients' lives through science. Our collaborative work culture fosters innovation and continuous improvement, providing employees with ample opportunities for professional growth and development in the pharmaceutical industry. With a strong commitment to quality and compliance, we empower our teams to lead impactful initiatives while ensuring a supportive environment that values diversity and inclusion.
Contact Details:
Bristol Myers Squibb EU Policy Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, PV Process Quality Lead in Uxbridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Bristol Myers Squibb EU Policy. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Bristol Myers Squibb EU Policy.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Bristol Myers Squibb EU Policy. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Bristol Myers Squibb EU Policy is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Manager, PV Process Quality Lead in Uxbridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Bristol Myers Squibb EU Policy!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Bristol Myers Squibb EU Policy that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Bristol Myers Squibb EU Policy!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Bristol Myers Squibb EU Policy, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Bristol Myers Squibb EU Policy
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Bristol Myers Squibb EU Policy that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Bristol Myers Squibb EU Policy’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
