At a Glance
- Tasks: Ensure compliance and quality in pharmacovigilance, driving strategic projects and collaborating globally.
- Company: Join Roche, a leader in healthcare innovation with a culture of respect and personal expression.
- Benefits: Flexible working environment, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team dedicated to advancing science and improving lives.
- Why this job: Make a real impact on patient safety and healthcare access worldwide.
- Qualifications: Deep knowledge of GVP/GCP regulations and experience in managing health authority inspections.
The predicted salary is between 63000 - 77000 £ per year.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
In this pivotal role, you'll ensure compliance, deliver quality, and drive strategic projects - overseeing key processes, collaborating with global stakeholders, and playing a crucial role in regulatory inspections. Your deep understanding of Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) safety requirements will be instrumental in upholding the highest standards of quality and compliance. This is a highly specialised, expert position focused on individual expertise, without direct line management responsibilities.
Act as a senior quality leader for our global pharmacovigilance (PV) quality organisation, safeguarding the compliance and quality standards that keep our medicines safe for patients. Own key license-to-operate activities, which may include:
- Serving as global process owner for the Pharmacovigilance System Master File (PSMF) - ensuring our safety systems meet Good Pharmacovigilance Practice (GVP) and other applicable requirements worldwide.
- Lead and support GVP and GCP Safety health authority inspections and business partner audits, representing quality and safety with confidence and shaping how we prepare, respond, and continuously improve.
- Drive strategic quality management initiatives and safety process redesign that integrate quality with efficiency, using data and digital tools to lift productivity and compliance.
- Lead integration workstreams for mergers and acquisitions, bringing new products and GCP/GVP data into our safety quality framework.
- Collaborate across a global, matrixed organisation - safety, clinical, regulatory, and quality partners - influencing and building consensus without relying on direct authority.
You bring deep, current knowledge of global GVP/GCP safety regulatory requirements and pharmacovigilance quality management systems. You are an excellent systems thinker and process designer, able to design solutions that are both compliant and efficient. You have proven experience managing and supporting health authority inspections and audits. You lead confidently in a matrix environment, motivating and aligning networked teams without direct line management authority. You are a strong, concise communicator and skilled stakeholder manager who uses data and digital tools to drive continuous improvement.
Together, we'll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases.
At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.
Senior PV Quality Director employer: Roche Holding AG
Roche Products Ltd. is an exceptional employer that fosters a collaborative and innovative work culture, particularly within the Cardiovascular, Renal & Metabolism (CVRM) team. Employees benefit from comprehensive professional development opportunities, a commitment to patient-centric solutions, and the chance to make a meaningful impact in obesity and cardiometabolic care. Located in the UK, Roche offers a dynamic environment where your contributions directly enhance healthcare outcomes and scientific understanding.
StudySmarter Expert Advice🤫
We think this is how you could land Senior PV Quality Director
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Roche Holding AG. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Roche Holding AG.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Roche Holding AG. 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 Roche Holding AG is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior PV Quality Director
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 Roche Holding AG!
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 Roche Holding AG 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 Roche Holding AG!
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 Roche Holding AG, 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 Roche Holding AG
✨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 Roche Holding AG 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 Roche Holding AG’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.
