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- Tasks: Lead quality processes in labelling and regulatory affairs, ensuring compliance and safety.
- Company: Join Amgen, a leader in biotech with a commitment to innovation and quality.
- Benefits: Flexible work options, generous rewards, and opportunities for career growth.
- Other info: Be part of a diverse community that values your ideas and contributions.
- Why this job: Make a real impact in the pharmaceutical industry while advancing your career.
- Qualifications: Degree educated with experience in Quality Management and regulatory affairs.
The predicted salary is between 60000 - 80000 £ per year.
In this vital role you will strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies. This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities. This role will be responsible for leading processes and activities related to the pharmacovigilance (GPvP) annual audit plan, the preparation and execution of audits, the investigation and monitoring of Quality events and supporting partner audits and regulatory inspections.
The Quality Lead role in the Safety & Medical Quality organization will lead proactive identification of compliance issues relating to processes and programs, and escalation to compliance and quality oversight bodies, and participate in quality investigations, management, and remediation. Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality. Ensure proactive identification of issues relating to processes, programs, and external relationships, elevate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation.
Assess and manage risks including providing input into the development of the annual GPvP audit plan. Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers. Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information. Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs. Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers. Support inspections and external audits, including preparing, conducting, and closing out response reviews. Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews. Develop long-term remediations and process improvements through Root Cause Analysis (RCA). Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA) and Effectiveness Verifications. Actively seek and implement innovative and proactive quality oversight methodologies.
What we expect of you:
- Degree educated
- Experience in Quality Management, Quality Compliance or other relevant risk‑based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
- Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
- Previous experience supporting regulatory authority inspections of pharmacovigilance activities
- Experience of leading and/or supporting process improvement initiatives
- Previous leadership or mentoring experience is ideal
What you can expect of us:
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Location: Ability to work flexibly from home with occasional office work from our Cambridge or Uxbridge next generation workspaces.
Equal Opportunity Statement: Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Quality Compliance Senior Manager - Labelling & Regulatory Affairs in Cambridge employer: Amgen SA
Contact Detail:
Amgen SA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Compliance Senior Manager - Labelling & Regulatory Affairs in Cambridge
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at Amgen or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into Amgen's values and recent projects. Show us that you’re not just another candidate; you’re genuinely interested in what we do and how you can contribute to our mission.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We love hearing about your past experiences, so structure your answers to highlight your skills and achievements clearly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Quality Compliance Senior Manager - Labelling & Regulatory Affairs in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Quality Compliance Senior Manager role. Highlight your knowledge of Good Pharmacovigilance Practice (GPvP) and any relevant leadership experience to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in the pharmaceutical industry and how your background makes you the perfect fit for our team at StudySmarter.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved processes or led successful audits in your previous roles to demonstrate your impact.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of your journey with StudySmarter!
How to prepare for a job interview at Amgen SA
✨Know Your Stuff
Make sure you brush up on Good Pharmacovigilance Practice (GPvP) and regulatory affairs. Familiarise yourself with the latest compliance metrics and be ready to discuss how you've applied these in your previous roles. This shows you're not just knowledgeable but also passionate about the field.
✨Showcase Your Leadership Skills
Since this role involves leading processes and activities, be prepared to share examples of your leadership experience. Talk about how you've mentored others or led process improvement initiatives. Highlighting your ability to guide teams will resonate well with interviewers.
✨Prepare for Compliance Scenarios
Think through potential compliance issues that could arise in labelling and regulatory affairs. Be ready to discuss how you would proactively identify and manage these risks. This demonstrates your critical thinking and problem-solving skills, which are essential for the role.
✨Engage with Questions
Don't forget to prepare thoughtful questions for your interviewers. Ask about their current challenges in quality compliance or how they envision the future of R&D processes. This shows your genuine interest in the company and the role, making you a memorable candidate.