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- Tasks: Lead GCP, GVP, & GLP QA strategy and ensure compliance with global regulations.
- Company: Dynamic pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Why this job: Make a significant impact in drug development and quality assurance.
- Qualifications: 10+ years in pharmaceutical development with expertise in GCP, GVP, and GLP compliance.
- Other info: Join a collaborative team dedicated to continuous improvement and excellence.
The predicted salary is between 72000 - 108000 £ per year.
Location: London
Reporting to: Vice President, Global Quality
Job Summary
The Director, GCP, GVP, & GLP QA is a key leadership role responsible for establishing and executing the strategy for GCP, GVP, & GLP compliance. This leader will drive the continuous improvement of the Quality System and ensure all research, clinical (GCP), and non-clinical (GLP) development activities, as well as pharmacovigilance (GVP), are conducted in full compliance with global regulations. This role provides critical quality oversight, manages regulatory agency inspections, and ensures a state of inspection readiness across all relevant functions.
Key Elements And Responsibilities
- Strategic Leadership: Provide overall strategic oversight for global GCP, GVP, & GLP QA activities, ensuring collaborative and compliant implementation of initiatives with all internal and external partners.
- Stakeholder Partnership: Act as a senior strategic partner to Clinical Development, Pharmacovigilance, and Non-Clinical leadership. Provide expert counsel and effectively influence senior stakeholders to navigate complex compliance challenges.
- Inspection & Audit Oversight: Lead and provide technical direction for all Health Authority inspections (GCP, GVP, GLP), including preparation, hosting, and ensuring robust and timely responses to any findings.
- Audit Strategy Development: Develop and execute the risk-based GCP/GVP/GLP audit strategy for all internal processes, investigator sites, and external service providers (e.g., CROs), and oversee the execution of the comprehensive audit program.
- Quality System & Continuous Improvement: Drive continuous improvement by leveraging QMS data, monitoring KPIs, and analysing risk; oversee the CAPA process to ensure effective solutions and maintain all GCP/GVP/GLP QA processes, standards, and the associated compliance training program.
- Risk Management & Business Continuity: Implement risk-based quality approaches for clinical development programs and provide ongoing quality risk monitoring. Raise early signals to leadership regarding any GCP, GVP, or GLP quality issues that pose a risk to business continuity and provide clear direction on mitigation measures.
- Regulatory Intelligence: Monitor major regulatory updates and industry trends, benchmarking through professional consortia and networking to identify and lead necessary change management opportunities.
Requirements
- Bachelor's degree in a scientific field.
- Minimum 10 years of pharmaceutical/biotechnology drug development experience, with at least 10 years in GCP, GVP, and GLP QA compliance.
- Expert-level knowledge in leading Health Authority inspections (GCP, GVP, GLP) and managing global, risk-based audit programs.
- In-depth, applied knowledge of applicable GCP, GLP, and GVP regulations and ICH guidelines.
- Proven track record of strong people management and the ability to build and develop a high-performing team.
- Outstanding communication, presentation, and influencing skills, with a demonstrated ability to hold senior leaders accountable and navigate complex problems.
- Strong risk management expertise, including issue identification, problem-solving, and decision-making.
- Working knowledge of all Clinical Development phases and processes.
Seniority level: Director
Employment type: Full-time
Job function: Other
Director, GCP, GVP, GLP QA in London employer: Orchard Therapeutics - U.S.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, GCP, GVP, GLP QA in London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. The more you engage with others, the better your chances of hearing about job openings before they even hit the market.
✨Ace the Informational Interview
Don’t be shy to reach out for informational interviews. It’s a great way to learn about the company culture and make a lasting impression. Plus, it shows your genuine interest in the role and can lead to referrals!
✨Showcase Your Expertise
When you get the chance to chat with potential employers, don’t hold back on sharing your insights and experiences. Use specific examples from your past roles to demonstrate how you can add value, especially in GCP, GVP, and GLP compliance.
✨Apply Through Our Website
Make sure to apply through our website for the best chance at landing that Director role. We love seeing candidates who take the initiative to engage directly with us, and it helps us keep track of your application!
We think you need these skills to ace Director, GCP, GVP, GLP QA in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Director, GCP, GVP, & GLP QA role. Highlight your expertise in compliance and quality oversight, as well as any relevant leadership experience.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this role. Share your passion for quality assurance and how your background in pharmaceutical or biotechnology development makes you an ideal candidate.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use quantifiable results to demonstrate how you've driven continuous improvement and managed successful audits or inspections in your previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. This way, we can ensure your application gets the attention it deserves and you can easily track your application status!
How to prepare for a job interview at Orchard Therapeutics - U.S.
✨Know Your Regulations
Make sure you brush up on the latest GCP, GVP, and GLP regulations before your interview. Being able to discuss specific guidelines and how they apply to the role will show that you're not just familiar with the basics but are also ready to lead compliance efforts.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams or projects in the past. Highlight your experience in managing audits and inspections, as well as how you've influenced senior stakeholders. This is a leadership role, so demonstrating your ability to guide others is crucial.
✨Prepare for Scenario Questions
Expect to face scenario-based questions that assess your problem-solving skills and risk management expertise. Think about past challenges you've encountered in QA compliance and how you navigated them. Be ready to explain your thought process and the outcomes.
✨Engage with the Interviewers
Don't forget that interviews are a two-way street! Prepare thoughtful questions about the company's quality strategy and how they approach continuous improvement. This shows your genuine interest in the role and helps you gauge if the company aligns with your values.
