At a Glance
- Tasks: Lead global sterility assurance and contamination control strategies in a dynamic biopharmaceutical environment.
- Company: Join Teva, a leading innovative biopharmaceutical company dedicated to improving health worldwide.
- Benefits: Enjoy generous leave, flexible schedules, tailored health support, and career development opportunities.
- Other info: Be part of a diverse and inclusive workplace that values fresh thinking and collaboration.
- Why this job: Make a real impact on product quality and patient safety in a collaborative culture.
- Qualifications: 15+ years in sterile manufacturing, microbiology, and quality assurance with strong leadership skills.
The predicted salary is between 63000 - 77000 £ per year.
We Are Teva
We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
How You'll Spend Your Day
We are looking for an experienced quality and compliance leader with deep expertise in sterility assurance, microbiology, and contamination control to join our Global Quality organization. In this highly visible global role, you will drive quality, compliance, and operational excellence across Teva's manufacturing network and external partners, supporting inspection readiness, regulatory compliance, modernization initiatives, and contamination prevention strategies. Working closely with Quality, Operations, R&D, Regulatory Affairs, Supply Chain, and Technical Operations teams, you will play a key role in advancing Teva's commitment to product quality and patient safety.
Travel Requirements: Up to 30% domestic and international travel.
Key Responsibilities
- Define and execute the global sterility assurance (SA) strategy across internal sites and CMOs.
- Own aspects of the global microbiology, CCS, aseptic processing, endotoxin control, sterilization, EM, water systems, and CCI governance frameworks.
- Lead global policy, standards, and procedural lifecycle management.
- Oversee modernization, harmonization, and digitalization efforts.
- Serve as primary SME for inspections (FDA, EMA, MHRA), readiness activities, and regulatory responses.
- Provide technical support to R&D programs, validation strategies, and regulatory submissions.
- Chair cross-functional sterility assurance councils and technical networks.
- Manage global risk assessments, mitigation strategies, and contamination/event investigations.
- Provide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements.
- Support/lead Global Quality Compliance Initiatives and contribute to Teva's Long Range Plan.
- Support critical product incident management events, including complex investigations and CAPA development.
- When needed, work collaboratively with the site compliance teams to perform walkthroughs and maturity assessments.
- Work with sites to ensure mock audits support a strong state of inspection readiness.
- When needed, write or execute protocol for deep dive quality compliance assessments and risk assessments.
- Help create, review and monitor the Quality Improvement Plans (QIP) to minimize compliance risk and improve quality performance.
- Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks.
- Contribute to Teva's Global Compliance Network through GxP interpretation, knowledge sharing, and regulatory guidance.
Your Skills and Experience
- Bachelor's degree in Chemistry, Microbiology, Pharmacy, Engineering, or another science-based discipline.
- 15+ years of experience in sterile/aseptic pharmaceutical manufacturing, microbiology, quality assurance, or quality compliance roles.
- Experience leading in both matrix and functional environments with technical, operational, and people leadership responsibilities.
- Extensive experience supporting health authority inspections, regulatory submissions, approvals, and lifecycle management.
- Strong knowledge of audit and inspection management, investigations, complaints, and CAPA programs.
- Deep aseptic processing expertise, including knowledge of isolators/RABS and Annex 1 requirements.
- Experience supporting Environmental Monitoring (EM), Contamination Control Strategies (CCS), and process simulations.
- Pharmaceutical quality manufacturing experience within sterile products, biologics, biosimilars, medical devices, or other highly regulated environments.
- Strong understanding of cGMP requirements, quality systems, microbiology, quality control, quality assurance, and quality compliance.
- Deep knowledge and experience in auditing, compliance, and quality oversight.
Are You?
- A recognized subject matter expert who can influence across a global organization.
- A strong problem solver with excellent analytical and technical writing skills.
- An effective communicator with strong presentation, collaboration, and negotiation skills.
- Comfortable operating in a complex, global matrix environment.
- Skilled in project management, prioritization, and change leadership.
- Proactive, self-motivated, and committed to continuous improvement.
- Able to navigate changing priorities while building strong partnerships across functions and cultures.
How We'll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.
If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Director Sterility Assurance and Contamination Controls employer: Teva
At Teva, we pride ourselves on being a leading biopharmaceutical company that fosters an inclusive and high-performing culture. As a Director - Category Manager EXM-Biologics, you will enjoy generous benefits, flexible working arrangements, and ample opportunities for professional growth through our dedicated career development platform, Twist. Join us in making a meaningful impact on global health while balancing your personal and professional life in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Director Sterility Assurance and Contamination Controls
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Teva. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Teva.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Teva. 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 Teva is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Director Sterility Assurance and Contamination Controls
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 Teva!
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 Teva 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 Teva!
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 Teva, 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 Teva
✨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 Teva 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 Teva’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.