Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The Sr. Manager, Quality (CCME) at Thermofisher is a leadership role, ensuring that GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is collaborative, working with fellow CCME team members, Operations, MSAT, Engineering and quality colleagues to implement innovative and pragmatic contamination control strategies to ensure we maintain compliance with regulatory standards.

The Sr. Manager, Quality (CCME) supports each of the GMP manufacturing sites within the PSG organization across multiple geographies, time zones and platforms.

Key Responsibilities:

• Assist site-based CCME colleagues in development of site contamination control strategies, aligned with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S.
• Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, and other relevant areas required by site CCME teams.
• Global review of EM trends from the PSG network and support site teams in remediation of adverse trends to maintain aseptic control. Promote contamination control awareness through data trending to drive improvements.
• Lead/support complex deviation or laboratory investigations and where appropriate, support CAPA plan definition and continuous improvement initiatives.
• Lead/support complex CCME related risk assessments.
• Ensure all GMP operations align with global regulatory requirements (FDA, EMA, MHRA, WHO, etc.). Mentor site based CCME SME’s prior to and during regulatory inspections, client and internal audits.
• Develop and deliver training programs related to sterility assurance, aseptic practices, gowning, microbiology, and contamination control.
• Process ownership of assigned quality system elements and support Community of Practice teams to develop open communication, achieve harmonization of processes and adoption of standard methodology across sites.
• Build and maintain strong relationships with all levels both within the organization and with our customers and partners.
• Facilitate continuous improvement and development of pragmatic solutions to identified issues.
• Guide facility and process design, including design of contamination controls and material/personnel and waste flows.
• Provide SME input into the qualification of manufacturing equipment impacting contamination control including selection and validation of decontamination/sterilization processes.
• Provide quality oversight of policies and SOPs aligned with the CCME function.
• Benchmark best industry practice through networking and attendance at key webinars, seminars, etc. Participate in Client discussions related to CCME and sterility assurance topics.
• Participate in the introduction of innovative technologies.
• Provide training and development to new and existing employees.
• Identify, lead and/or participate in global harmonization/efficiency projects.

Qualifications:

Minimum of BSc. in science related field, preferably Microbiology or Biological Sciences.

>10 years experience working in a GMP environment with direct experience of operational support, contamination control and Microbiology testing.

Physical Requirements:

Remote role with requirement for international travel to TFS site locations (30-40% travel)