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- Tasks: Lead global Clinical QA audit strategies and drive innovative partnerships.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Inclusive work environment, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on health by shaping clinical audit strategies.
- Qualifications: Bachelor's degree in science; 12+ years in compliance or R&D.
- Other info: Dynamic role with travel opportunities and a focus on talent development.
The predicted salary is between 54000 - 90000 £ per year.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Position Summary
The Director, QA Clinical Audit Strategy will be a key member of the R&D Quality (RDQ) Clinical QA leadership. This role will lead a global team of Clinical QA Program Leads and drive cross-functional partnerships in a highly matrixed organization. Main responsibilities will include, but are not limited to:
- Drives and delivers audit strategies/capabilities across all GCP audit types (including Clinical Investigator Site Audits, Clinical Program Audits, System Audits, ESP Audits, and LOC Audits), ensuring implementation of risk-based methodologies and innovative tools, consistently across programs.
- Drives close partnership between Clinical QA audit strategy and execution teams to foster collaboration, ensure seamless E2E clinical audit process and strong connectivity of all Clinical QA audit data to enhance the overall value of Clinical QA.
- Drives cross-domain and cross-functional partnerships to ensure Clinical QA audit strategies continue to evolve in line with emerging needs and add value to the overall Quality and Compliance of JJIM clinical programs.
- Interfaces with Quality partners and business partners specifically supporting TA Clinical Programs to ensure audit strategies are properly developed and effectively executed.
- Conducts GCP audits & support GxP Audits including resolution of CAPAs when applicable.
- Serves as the primary contact for Clinical QA related to HA Inspections, including inspection readiness and coordinating with other functions as needed.
- Leads and develops a team of direct reports; coaches and mentors other Clinical QA team members to support talent development and training, foster effective leadership skills and competencies to shape a collaborative and efficient auditor organization that meets current and future business needs.
- Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.
Qualifications
Education: A minimum of a Bachelor of Science (BSc) degree is required with a focus in science, life science or pharmaceutical science is required. An advanced degree (M.D, Ph.D, MSc or Pharm D) would be desirable.
Required: Deep knowledge and understanding of the drug development process, GxP functional compliance regulations (national and international), sound research and development practices, scientific terminology, company quality assurance procedures and policies, and quality evaluation techniques. Excellent communication, organization, investigation, and negotiation skills, and be diplomatic. Advanced problem-solving skills. Advanced strategic thinking related to new and emerging technologies and analytics, and ability to identify opportunities where creative capabilities may be applied within QA audit processes. Track record of leading global strategic initiatives in the R&D Quality and Compliance areas. Experience of leading and advancing a global team of direct reports. A minimum of 12 years relevant work experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP regulated discipline). This position may require up to 20% domestic & international travel.
Director, Clinical Audit Strategy in High Wycombe employer: Johnson and Johnson
Contact Detail:
Johnson and Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Clinical Audit Strategy in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Johnson & Johnson. A friendly chat can open doors and give you insider info about the company culture and the role.
✨Tip Number 2
Prepare for the interview by researching the latest trends in clinical audit strategies. Show us that you’re not just familiar with the basics but also passionate about how they evolve and impact healthcare.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about specific situations where you’ve led teams or driven strategic initiatives—make it memorable!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining our team at Johnson & Johnson.
We think you need these skills to ace Director, Clinical Audit Strategy in High Wycombe
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director, Clinical Audit Strategy role. Highlight your relevant experience in GxP compliance and audit strategies, as this will show us you understand what we're looking for.
Showcase Your Leadership Skills: Since this role involves leading a global team, don’t forget to emphasise your leadership experience. Share examples of how you've developed teams or driven strategic initiatives in the past – we love to see that!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and achievements quickly.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Johnson and Johnson
✨Know Your Stuff
Make sure you have a solid understanding of GxP compliance regulations and the drug development process. Brush up on relevant scientific terminology and quality assurance procedures, as these will likely come up during your interview.
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate your ability to lead and develop teams. Prepare examples of how you've successfully managed global teams and driven strategic initiatives in the past. Highlight your coaching and mentoring experiences to show you're ready to foster talent.
✨Be Ready for Problem-Solving
Expect questions that assess your advanced problem-solving skills. Think of specific challenges you've faced in previous roles and how you approached them. This will showcase your strategic thinking and ability to adapt to new technologies and analytics.
✨Communicate Effectively
Excellent communication is key in this role. Practice articulating your thoughts clearly and concisely. Be prepared to discuss how you've built cross-functional partnerships and ensured seamless collaboration in past projects, as this will be crucial for the position.