The Sr Manager Quality, Contamination Control Strategy Lead is responsible for establishing, maintaining, and continuously improving the contamination control strategy at a sterile injectable manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and contamination control initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).
The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. In addition, the Sr Quality Manager is expected to partner with QALO and operations leadership, training leadership, and the Contamination Control Strategy Team.
The responsibilities:- Owns the aseptic observer program, including oversight of aseptic practices, cleanroom behavior, and gowning:
- Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
- Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
- Leads the development and implementation of the Contamination Control Strategy (CCS) according to EU GMP Annex 1 and supports its governance in line with applicable regulatory requirements, organizing routine team meetings, annual updates of strategy document, and SME presentation of strategy for audits
- Assist 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
- Collaborates 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.
- Supports contamination control assessments related to qualification and validation of equipment, utilities, (e.g. HVAC, WFI) isolators, RABS, and cleaning / disinfection procedures.
- Mentors and assists with training aseptic operators, and QA personnel in and contamination control. Responsible for Provide guidance on improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence.
- Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances
- 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.
The qualifications:- Education: Bachelors degree in Microbiology (preferred), Biology, Pharmacy, or related science.
- Masters degree or higher in Microbiology or Pharmaceutical Sciences is preferred
- Minimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA roles, including at least 5 years in SME capacity related to contamination control.
- Demonstrated leadership or cross-functional team experience in aseptic processing environments (e.g. controlled areas (specifically A/B, isolators, OPEN and CLOSED RABS systems).
- Proven track record of successful regulatory inspection participation (FDA, EMA, or equivalent) as SME for contamination control topics
- Strong knowledge of EU GMP Annex 1, 21 CFR parts 210/211, USP, , , , and current industry best practices
- Understanding of aseptic processing, data interpretation, aseptic filling processes and equipment strategies, CCS design, and Quality Risk management (ICH Q9).
- Strong communication skills as the role is expected to interface with clients, regulatory agencies, and site leadership, and being able to make decisions.
- Strong technical writing skills for strategy documents, assessments and investigations.
- Strong attention-to-detail, decision-making capability, and problem-solving in complex technical environments
- Ability to train, mentor, and coach staff in aseptic technique and contamination control.
Working conditions:- Role requires frequent presence in Grade A/B aseptic environments; gowning certification is required.
- May require occasional off-shift, off-hours, support during media fills, regulatory inspections, or critical interventions
In return, you'll be eligible for[1]
:- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
DisclaimerThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
