Sterility Assurance Manager

About the role

The Sterility Assurance Manager is responsible for establishing, maintaining, and continuously improving the site's strategy at a sterile fill / finish manufacturing facility. They need to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and sterility assurance initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site.

Responsibilities

• Promote understanding of and compliance to aseptic processes and related regulations such as EU Annex 1 & the FDA’s aseptic processing guide.
• Conduct regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements and provide real time coaching to aseptic staff.
• Define, oversee and where necessary improve the EM & Contamination Control programs.
• Aid with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations.
• Serve as the SME during regulatory inspections and audits regarding aseptic processing, and contamination control.
• Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made.
• Collaborate with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS), to ensure appropriate cleanroom qualification, media fill (process simulation), environmental monitoring, and glove/sleeve integrity programs.
• Support assessments related to qualification and validation of equipment, utilities (e.g. HVAC, WFI), and fill / finish equipment (e.g. isolators).
• Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with overseeing aseptic manufacturing and must be appropriate to the related tasks each person conducts.
• Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances.
• Review & approve any major/critical deviation and any change proposals with aseptic processing impact.
• Review and approve GMP documents related to aseptic processing, (SOPs, protocols, reports, batch records).
• Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.

Requirements

• Bachelor’s degree in a Microbiology or similar/related technical field required.
• Substantial experience, minimum 7-10 years’ working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing or aseptic manufacturing site.
• Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part 210/211 and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.

Qualifications

• Deep understanding of GMP regulations and global quality standards.
• Excellent communication and presentation skills.
• Strong organizational and prioritization capabilities.
• Skilled in technical writing and analytical problem-solving.
• Collaborative leadership style with a continuous improvement mindset.

Skills

• Ability to gown for cleanroom environments.
• Capacity to read and review documentation for extended periods.
• Must be able to talk, hear, sit, and stand for long durations.
• Occasionally required to lift, walk, reach, stoop, kneel, or crouch.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. Compensation And Benefits The salary range estimated for this position based in Massachusetts is $103,100.00–$154,700.00. 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 programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: here