QC Section Head – Environmental Monitoring

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

Job Description

Job Description

Business Job Title: Head of QC Section - Environmental Surveillance

Job Profile Title: (Internal title) Supervisor, QC

Direct Report To: QC Manager - Microbiology

Group/ Division: PSG or equivalent experience

Career Band: 06

Career Track: Management

Position Location: Swindon

Number of team members: 11

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. stands as a pioneer in serving science, with annual revenue exceeding $25 billion. We are dedicated to empowering our clients to improve the health, cleanliness, and safety of the world. From accelerating life sciences research to improving patient diagnostics and therapies, we empower innovation worldwide through industry-leading brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon. Join our distributed team of 75,000+ colleagues who bring innovative science to life every day.

For more information, please visit www.thermofisher.com

Why This Role Matters

Lead a microbiology group to maintain sterility and safety standards for pharmaceutical products, improving both patient health and product quality.

Position Summary:

Lead the Environmental Monitoring QC department coordinating a microbiology team, ensuring the quality of pharmaceutical products in a sterile regulated setting.

You will be accountable for the management of a team who provide support to the business with regards to microbiology testing for batch releases in following areas:

• Lead a team that is responsible to ensure cleanrooms quality complies to microbial and total particulate count assessments to maintain cleanroom sterility.
• Supervise microbial identification of environmental isolates to support contamination control and investigation.
• Oversee utilities management, compressed air systems, ensuring compliance and reliability.
• Manage cleanroom license training to maintain staff competency and regulatory compliance.
• Facilitate attainment of section benchmarks, including QC deviations, CAPAs, change controls, and batch release activities.
• Lead environmental monitoring qualification for cleanrooms, ensuring ongoing compliance with regulatory standards.
• Support and coordinate testing of biological indicators for sterile processing and decontamination systems on site.
• Oversee qualification and validation of microbiology testing methods, ensuring scientific rigor and regulatory adherence.
• Deliver high-level technical support and implement scientific proficiency throughout the microbiology and quality units.
• Facilitate global regulatory updates and lead site implementation of new guidelines and processes.

What Makes This Role Exciting

• Encourage Innovation: Head an important team at the forefront of upholding sterile manufacturing quality, directly affecting patient safety and product integrity.
• Make an Impact: Your leadership will help ensure that life-saving pharmaceutical products meet the highest quality standards globally.
• Continuous Growth: Access to continuous training, global networking, and opportunities to contribute to brand new microbiology initiatives.
• Collaborative Culture: Work alongside passionate professionals in a supportive, inclusive environment that values different perspectives and develop creativity.
• Be a Change-Maker: Champion process improvements and lead projects that enhance efficiency, compliance, and sustainability.

Section Responsibilities

• Manages a team of Microbiologists in the Product Integrity section.
• Manage department Key Performance Indicators, making sure targets are met on time.
• Conduct one-to-ones, performance reviews, and goal setting for team members.
• Work together with different business sectors to secure timely accomplishment of tasks that meet business, client, and customer requirements.
• Write and complete protocols and reports (URS/DQ/IQ/OQ/PQ) and organize qualification activities.
• Ensure continuous audit preparedness to assist client, corporate, and regulatory inspections consistently.
• Lead, plan, coordinate, and/or complete tasks to keep control and compliance.
• Maintain a visual management system displaying the status of all key benchmarks for the section.
• Lead and support investigations impacting analytical testing.
• Extend technical aid and recommendations to QC Microbiology testing teams, functioning as the primary resource for addressing challenges.
• Collaborate with other QC Microbiology Section Heads and teams to improve compliance, efficiency, HSE, and working conditions.
• Guarantee timely submission of trend reports for water and bioburden monitoring.
• Guarantee adherence to GMP, Data Integrity, and Good Documentation Practice (GDP) in all tasks.
• Ensure own and team training is completed timely and in compliance with GMP before task execution; develop a cross-functionally trained team.
• Identify and drive Practical Process Improvement (PPI) initiatives focusing on improved efficiency and compliance.
• Undertake/support self-inspections, GEMBA walks, and Huddle meetings as relevant.
• Undertake ad-hoc activities as required by the business.
• Support and encourage a “Quality Culture” and uphold company 4i values throughout QC.

Technical Responsibilities

• Act as Subject Matter Expert during audits and inspections with regulators and clients.
• Ensure QC Microbiology processes remain current with regulatory and pharmacopeial updates.

Leadership Responsibilities

• Management: Lead team and projects to ensure clear understanding of results and performance targets.
• Coaching: Support team members in reaching achievements and career growth.
• Team Building: Encourage healthy relationships, interpret team dynamics, and cultivate a harmonious, collaborative work environment.
• Decision Making: Make informed decisions, solve problems proactively, and continuously improve processes.
• Integrity: Maintain and promote integrity, creating a positive workplace environment.
• Communication: Communicate clearly and confidently with the team and senior management.
• Intensity: Demonstrate passion and expertise to drive improved outcomes.
• Lead effectively in line with GMP/GDP requirements and uphold 4i (Integrity, Involvement, Intensity, Innovation) values, policies, and procedures.

Environment, Health & Safety (EH&S)

• Understand emergency procedures and align with safe systems of work.
• Maintain adherence to environmental, health, and safety regulations, signage, and instructions consistently.
• Promptly report and investigate all accidents, near misses, and breaches of rules.
• Ensure all materials have associated COSSH information and safety requirements included in test procedures.

Minimum Requirements / Qualifications

• Degree in Microbiology, Biological Sciences, or a closely related scientific field.
• 5-10 years’ substantial experience working in pharmaceutical QC, preferably within a sterile manufacturing site.
• Extensive technical expertise and practical involvement in calibrating and validating analytical systems and processes like balances, incubators, microbiology test methods, microorganism identification, and utilities.
• Minimum 2 years’ experience in team leadership including coordination, absence management, appraisals, problem resolution, motivation, coaching, and mentoring.
• Proficient in microbiology tools and methods, possessing a strong grasp of cGMP, GDP, GLP, pharmacopeial practices, and compliance standards.
• Good understanding of aseptic processes and techniques.
• Profound understanding of Data Integrity principles and how they are practically applied in laboratories.
• Effective verbal and written communication skills, including delivering presentations, facilitating meetings and training, and preparing reports.
• Excellent collaboration and conflict resolution skills.
• Strong technical writing skills.
• Exhibits eagerness and zeal for gaining insights and grasping methods and protocols.
• Capability to excel in a dynamic setting.

Our Commitment to Diversity, Equity & Inclusion

At Thermo Fisher Scientific, we are committed to fostering innovation through diverse teams. We’re committed to building an inclusive workplace where every voice is heard and valued.

Benefits

• Competitive salary and performance bonuses
• Comprehensive health and wellness programs
• Flexible working options and support for work-life balance
• Career development programs including mentoring and leadership training
• Access to state-of-the-art technology and resources

Within Thermo Fisher Scientific, every one of our 70,000 outstanding individuals has a distinct narrative to share. Join us and contribute to our outstanding mission—empowering our clients to foster a healthier, cleaner, and safer world.