- Are you the person everyone turns to when contamination control challenges arise?
- Do you have the expertise to shape sterility assurance strategies across a global pharmaceutical manufacturing network?
- Ready to influence quality standards that ultimately help deliver life-changing medicines to patients worldwide?
If so, this could be the career-defining opportunity you've been waiting for.
Our client is a global leader in pharmaceutical manufacturing and life sciences, committed to advancing healthcare and delivering innovative solutions that improve lives around the world. As Director, Quality – Contamination Control & Microbial Excellence, you'll play a pivotal role in ensuring the highest standards of microbiological quality, sterility assurance, and contamination control across a global manufacturing network.
This is more than a quality leadership role. It's an opportunity to influence global standards, drive innovation, support critical manufacturing operations, and help ensure patients receive safe, high-quality medicines.
The Opportunity
As the global subject matter expert for Contamination Control and Microbial Excellence, you'll work closely with site quality leaders, operations teams, engineering, technical services, and corporate quality colleagues to establish and implement world-class contamination control strategies across multiple manufacturing facilities.
You'll be at the forefront of ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1, FDA guidance, ISO standards, and PIC/S requirements, while helping sites continuously improve their contamination control programs and microbiological performance.
What You'll Be Doing
- Lead and support the development, implementation, and continuous enhancement of site Contamination Control Strategies (CCS) across a global manufacturing network.
- Serve as the SME for microbiology, contamination control, sterility assurance, environmental monitoring, aseptic processing, cleanroom operations, cleaning and disinfection programs.
- Review and analyze environmental monitoring trends across multiple sites, identifying risks and driving proactive improvements.
- Provide expert support for complex investigations, deviations, root cause analyses, CAPA development, and risk assessments.
- Partner with engineering and project teams to influence facility design, cleanroom layouts, material and personnel flows, and contamination control considerations from concept through qualification.
- Support inspection readiness activities and help sites successfully navigate regulatory inspections and audits.
- Champion innovation, digitalization, and continuous improvement initiatives across the contamination control and microbiology landscape.
- Drive consistency, standardization, and best-practice sharing across multiple global manufacturing sites.
What We're Looking For
You are a highly respected microbiology or sterility assurance professional who combines deep technical expertise with the ability to influence at a strategic level.
Essential Experience:
- Bachelor's degree (or higher) in Microbiology, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.
- Significant experience supporting sterile or low-bioburden pharmaceutical manufacturing environments.
Strong expertise in:
- Aseptic manufacturing
- Environmental monitoring
- Cleanroom classification and contamination control
- Sterility assurance programs
- Cleaning and disinfection strategies
In-depth knowledge of:
- EU GMP Annex 1 (2022)
- FDA Aseptic Processing Guidance
- GMP regulations and quality systems
- Experience implementing and maintaining Contamination Control Strategies.
- Knowledge of barrier technologies such as isolator systems.
- Proven success supporting regulatory inspections and audit defence activities.
- Exceptional stakeholder management and cross-functional leadership skills.
What's on Offer?
- Competitive compensation package
- Annual performance bonus
- Comprehensive healthcare and wellbeing benefits
- Professional development and career progression opportunities
- The opportunity to influence quality and contamination control strategy on a global scale
Make a Global Impact
This is a rare opportunity to join a world-class organisation and become a key leader in shaping contamination control and microbiological excellence across an international manufacturing network.
If you're passionate about sterility assurance, contamination control, and driving quality excellence in pharmaceutical manufacturing, we'd love to hear from you so apply to have a conversation to discuss further.