At a Glance
- Tasks: Lead global quality and compliance for pharmacovigilance systems and ensure regulatory adherence.
- Company: Join Seqirus, a leader in the pharmaceutical industry with a commitment to innovation.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for strategic influence and career advancement.
- Why this job: Make a significant impact on global health by ensuring safety and compliance in drug development.
- Qualifications: 10+ years in pharmaceutical QA, strong leadership skills, and deep regulatory knowledge.
The predicted salary is between 80000 - 100000 € per year.
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands-on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business.
You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long-term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but you're equally engaged in the details that matter—ensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready.
The Role
You will direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates. Your focus is on three core pillars: Strategic Governance, Operational Excellence, and Regulatory Intelligence.
Key Accountabilities:
- Strategic Leadership: Harmonize processes within Global PVRQA and across other GxP areas. Contribute to the larger strategic vision of Global R&D Quality and interact with the Leadership Team to ensure continuous alignment.
- Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors.
- Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and 3rd party audits.
- System Oversight: Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).
- Cross-Functional Expertise: Provide GVP consultancy and cross-GxP expertise (GCP, GDP, GCLP) to ensure coordination across functional areas, including Commercial and Clinical Development.
- Operational Management: Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.
- Resource Stewardship: Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.
- Continuous Improvement: Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.
Your Profile
The successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system.
Qualifications & Experience:
- Education: Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; an advanced degree is preferred.
- Industry Tenure: 10+ years of pharmaceutical industry experience specifically within Quality Assurance.
- Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.
- Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research.
- Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions.
Leadership Attributes:
- Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions.
- Communication & Influence: Excellent communication, negotiation, and influencing skills across all levels of the business.
- Operational Rigor: Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans.
Head, PV and Regulatory QA in Maidenhead employer: CSL Plasma Inc.
At Seqirus UK in Maidenhead, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. Our commitment to employee growth is evident through comprehensive training programmes and opportunities for advancement within the global pharmacovigilance landscape. With a focus on strategic governance and operational excellence, we offer a dynamic work environment where your expertise will directly impact patient safety and regulatory compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Head, PV and Regulatory QA in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to folks in the industry on LinkedIn or at events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Tailor your answers to show how your experience aligns with their values and goals.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online platforms. The more you rehearse, the more confident you'll feel when it counts.
✨Tip Number 4
Don't forget to follow up after interviews! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the role.
We think you need these skills to ace Head, PV and Regulatory QA in Maidenhead
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Head of PV and Regulatory QA role. Highlight your leadership experience and any relevant regulatory knowledge to catch our eye!
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, showcasing your strategic acumen and operational expertise. We love seeing genuine enthusiasm for the position!
Showcase Your Achievements:When detailing your past roles, focus on your achievements rather than just responsibilities. Quantify your successes where possible—numbers speak volumes and help us see the impact you've made in previous positions.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining the StudySmarter team!
How to prepare for a job interview at CSL Plasma Inc.
✨Know Your Stuff
Make sure you have a solid understanding of pharmacovigilance processes and regulatory guidelines. Brush up on GVP/GCP regulations and be ready to discuss how you've applied them in your previous roles.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing cross-functional teams. Be ready to discuss how you've influenced strategic decisions and driven operational excellence in past positions.
✨Be Audit-Ready
Since the role involves audit strategy, think about your experiences with internal and external audits. Prepare to share specific instances where you successfully managed inspections or improved compliance processes.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Given the importance of communication in this role, be prepared to demonstrate your negotiation and influencing skills during the interview.
