Sr Manager Quality, Contamination Control Strategy Lead

About 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, 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

Benefits

Additional Information

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: 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.

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