Strategy Manager

Why join Team Simtra? Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways. Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health. The role 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, Annex1) 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 the 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 Annex1 and supports its governance in line with applicable regulatory requirements, organizing routine team meetings, annual updates of strategy documents, and SME presentation of strategy for audits. Assists with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations. Serves as the SME during regulatory inspections and audits regarding aseptic processing and contamination control. Prepares and presents 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 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 contamination control. Provides guidance on improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence. Participates as needed in investigation and resolution of aseptic failures, sterility test failures, environmental monitoring excursions, adverse trends and related aseptic non‑conformances. Reviews and approves GMP documents related to aseptic processing (SOPs, protocols, reports, batch records). Leads 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 Annex1, 21CFR parts210/211, USP71,85,1116,797,1207 and current industry best practices. Understanding of aseptic processing, data interpretation, aseptic filling processes and equipment strategies, CCS design, and Quality Risk management (ICHQ9). Strong communication skills as the role is expected to interface with clients, regulatory agencies, and site leadership, and 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 GradeA/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 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 Disclaimer This 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. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: #J-18808-Ljbffr