Director, Quality (Contamination Control and Microbial Excellence)

RXinsider LTD.; Greenville (NC); On-site; USD 146,000 - 218,000; Full time

Benefits offered by this job

Health plans

Vision plan

Commuter benefits

Tuition reimbursement

120 hours PTO and holidays

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific in North Carolina is seeking a Director of Quality (Contamination Control and Microbial Excellence) to lead global contamination control and sterility assurance across PSG sites. The role collaborates with Operations, MSAT, Engineering and quality peers to define and implement policies ensuring compliance with current regulatory requirements.

The role requires expertise in microbiology, environmental monitoring, aseptic processing, and GMP/Annex 1 standards, with

Qualifications

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.
• 5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.
• Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.
• Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance.
• Prior experience with regulatory inspections and audit defense.

Responsibilities

• Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO and PIC/S.
• Provide subject matter expertise in microbiology, microbiological methods, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management.
• Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms.
• Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives.
• Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.
• Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).
• Inspection Readiness
• Support digitalization and innovation across PSG sites

Skills

Cross-functional collaboration

Regulatory inspections

Effective communication

GMP knowledge

Education

Bachelor’s degree in Microbiology

Tools

RABS

Isolators

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

DESCRIPTION

The Director, Quality (Contamination Control and Microbial Excellence) at Thermofisher plays a critical role in ensuring that all GMP operations maintain the highest standards of contamination control, sterility assurance and microbiological excellence. This position is a collaborative role, working with fellow CCME team members, Operations, MSAT, Engineering and quality colleagues.

The role is responsible for the definition and implementation of global policies and standards related to contamination control, sterility assurance and microbiology across all PSG sites to ensure alignment, standardization and compliance with current regulatory requirements.

ROLE AND RESPONSIBILITIES

• Support site based CCME colleagues to develop, implement, and maintain site contamination control strategies based on contamination control risk assessment in alignment 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, cleaning and disinfection and other relevant areas required by site CCME teams and corporate quality management.
• Support global review of EM trends from the PSG network and work with site teams to remediate adverse trends and maintain environmental control in all cleanrooms.
• Provide above-site support and direction to PSG sites for complex deviation or laboratory investigations related to Microbiology, Contamination Control and Sterility Assurance. Where appropriate, support with CAPA plan definition, preventive measures and continuous improvement initiatives.
• Provide above-site support and direction to PSG sites for complex risk assessments related to Microbiology, Contamination Control and Sterility Assurance.
• Provide guidance during facility and process design, including design led contamination controls and material/personnel and waste flows. Provide SME input into the qualification of manufacturing equipment and cleanroom that impact CCME including proper selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).
• Inspection Readiness
• Support digitalization and innovation across PSG sites

REQUIREMENTS

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related field.
• 5–10 years experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.
• Strong understanding of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.
• Deep knowledge of GMP, Annex 1 (2022 revision), FDA aseptic guidance
• Understanding of barrier technologies (RABS, isolators) and their implementation
• Effective communicator, able to influence and collaborate with cross-functional teams
• Prior experience with regulatory inspections and audit defense.
• Experience with CCS implementation preferred

Compensation And Benefits

The salary range estimated for this position based in North Carolina is $145,500.00–$218,250.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards