At a Glance
- Tasks: Lead a team to ensure top-notch product quality and compliance in a dynamic pharmaceutical environment.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, a bonus scheme, and flexible benefits.
- Other info: Great opportunities for professional growth and a culture of operational excellence.
- Why this job: Make a real impact on product quality while developing your career in a supportive team.
- Qualifications: Life Science degree and experience in the pharmaceutical industry required.
The predicted salary is between 36000 - 60000 £ per year.
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion. To support our growth, we’re now looking for a collaborative, driven and proactive Quality Manager.
You will be managing a UK based team of four and take a leading role in upholding the highest standards of product quality and compliance. You’ll ensure that all Quality operations run seamlessly and meet the rigorous requirements of GxP regulations, Clinigen Quality Systems and global industry standards.
Key Responsibilities:- Take ownership of Clinigen’s quality and technical activities as a global Marketing Authorisation Holder (MAH).
- Lead relationships with Contract Manufacturing Organisations (CMOs), distributors, and quality partners worldwide.
- Oversee quality investigations, including product complaints, deviations, CAPAs, and change controls.
- Manage key quality documentation such as Product Quality Reviews (PQRs), master batch records, and product files.
- Coordinate product stability programmes and support new product onboarding in collaboration with cross-functional teams.
- Plan and conduct GxP audits of CMOs, laboratories, and warehouses, ensuring supplier qualification and compliance.
- Support regulatory and quality system development, including internal audits and training.
- Act as a Quality ambassador, promoting GMP/GDP compliance, continuous improvement, and a culture of operational excellence.
- Ensure all Quality Technical Agreements are current and that product safety and compliance are maintained at all times.
- Prepare for and support audits (customer, supplier, and regulatory) while contributing to data analysis and continuous improvement initiatives.
- Take proactive ownership of your own professional development and stay informed on key compliance topics such as falsified medicines.
- Life Science degree or equivalent.
- Substantial experience within the pharmaceutical industry.
- Previous experience working directly for a Marketing Authorisation Holder is beneficial.
- Previous experiences in managing relationships with Contract Manufacturing Organisations is beneficial.
- A strong working knowledge of GMP and GDP, across dosage forms.
- Experience of regulatory inspections.
- Proven ability of accurate and timely completion of tasks.
- Adaptable to changing situations, with a proactive positive, flexible, assertive, can do attitude.
- Good influencing and stakeholder management skills.
- Strong written and verbal communication skills.
- Able to influence and lead by example, clearly communicating plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions.
- Able to delegate and prioritise effectively, considering individual and team strengths and development areas.
- Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail.
- Previous experience as a line manager is beneficial.
- 27 days holiday plus bank holidays.
- Discretionary Bonus Scheme.
- Pension contributions 4.5% matched.
- Life assurance 4 x annual salary.
- Flexible Benefits Platform with £25/month Company contribution.
- Annual salary review.
- Independent financial advice service.
- Enhanced Employee Assistance Programme.
- Shopping discounts with retailers.
- Long service awards.
- Recognition scheme.
Quality Manager - Commercial Products in Surrey employer: Clinigen
Clinigen is an exceptional employer that fosters a collaborative and dynamic work environment, perfect for those looking to make a meaningful impact in the pharmaceutical industry. With a strong commitment to employee growth, Clinigen offers extensive professional development opportunities, competitive benefits including a discretionary bonus scheme, and a flexible benefits platform, all while being part of a rapidly expanding global company headquartered in the UK. Join us to be at the forefront of quality management and compliance, where your contributions will be valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager - Commercial Products in Surrey
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Clinigen. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
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 Clinigen.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Clinigen. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨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 Clinigen is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Manager - Commercial Products in Surrey
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 Clinigen!
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 Clinigen 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 Clinigen!
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 Clinigen, 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 Clinigen
✨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 Clinigen 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 Clinigen’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.
