At a Glance
- Tasks: Ensure compliance and quality in pharmacovigilance, driving strategic projects and collaborating globally.
- Company: Join a leading healthcare company dedicated to advancing science and improving lives.
- Benefits: Flexible working, competitive salary, and opportunities for professional growth.
- Other info: Diverse and inclusive workplace with a commitment to innovation.
- Why this job: Make a real impact on patient safety and healthcare innovation.
- Qualifications: Expertise in GVP/GCP safety requirements and strong stakeholder management skills.
The predicted salary is between 60750 - 74250 £ per year.
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.
The Opportunity
- 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.
Where pay transparency applies, details are provided based on the primary posting location.
For this role, the primary location is Welwyn.
If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
A healthier future drives us to innovate.
Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come.
Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products.
We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.
Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd.
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.
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Senior PV Quality Director in England employer: Roche
At Roche, we pride ourselves on fostering a culture that values individuality and encourages personal growth. As a Field Service Engineer in the North Region, you will not only contribute to life-saving healthcare solutions but also benefit from a supportive work environment that promotes open dialogue and collaboration. With opportunities for continuous development and a commitment to diversity, Roche is an exceptional employer dedicated to creating a healthier future for all.
StudySmarter Expert Advice🤫
We think this is how you could land Senior PV Quality Director in England
✨Unlock Networking Opportunities
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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.
✨Leverage Internships for Full-time Roles
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✨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 is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior PV Quality Director in England
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!
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 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!
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, 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
✨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 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’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.
