Senior Manager, Quality Control
Senior Manager, Quality Control
Posted on :
26-07-2025
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1 Vacancy
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Job Description
COMPANY MISSION
At eGenesis we aspire to deliver safe and effective human transplantable cells tissue and organs utilizing the latest advancements in genome editing.
eGenesis is seeking an experienced and proactive Senior Manager Quality Control to lead the design implementation and continuous improvement of the Environmental Monitoring (EM) and Microbiology programs across our GMP manufacturing facilities in Rensselaer (REN) and Middleton (MID). This role will have dual responsibilities: overseeing routine EM operations and leading the operational readiness of the new QC Microbiology lab at the MID site including strategy and execution for water sampling microbial ID capabilities and critical QC systems. This individual will manage a growing team and collaborate cross-functionally with Manufacturing Facilities and QA. The position reports to the Senior Director Head of Quality.
PRIMARY RESPONSIBILITIES
- Oversee environmental monitoring programs (viable/non-viable air surface personnel water) at REN and MID to ensure compliance with cGMP and regulatory standards (FDA EU Annex 1).
- Lead daily EM operations data review/trending excursion management and CAPA implementation.
- Drive cross-functional contamination control initiatives and risk mitigation strategies.
- Act as the primary SME during audits and inspections for EM contamination control and microbial trending.
- Lead the buildout and qualification of the new QC Microbiology lab at the Middleton (MID) site to support in-house EM testing and microbial identification capabilities.
- Oversee qualification of QC instruments (e.g. incubators particle counters ID systems like MALDI-TOF qPCR) utilities and workflows supporting microbiology testing.
- Establish and validate a site-wide water sampling and testing strategy aligned with regulatory standards and phase-appropriate GMP compliance.
- Author and/or review protocols and reports related to lab qualification method validation and readiness assessments.
- Directly supervise and mentor QC team members responsible for EM sampling lab operations and method execution.
- Collaborate with QA Manufacturing Validation and Facilities teams to align EM practices and lab readiness with site and program needs.
- Participate in facility and equipment readiness reviews CCRB and project planning meetings to ensure Quality alignment.
- Support harmonization of QC systems SOPs and training across sites for a unified Quality culture.
- Develop and maintain SOPs forms protocols and work instructions related to EM and QC Microbiology functions.
- Ensure timely and accurate documentation in LIMS QMS (e.g. Veeva Qualio) and related quality systems.
- Lead or support deviation investigations and change controls related to environmental excursions water testing or lab performance.
- This position will require some travel (20% of time) between manufacturing site but primary location will be Middleton WI.
BASIC QUALIFICATIONS
- BS/MS in microbiology biology or a related scientific discipline with 3-5 years industry experience in a QC laboratory.
- Proficient in microbiology methods (plate enumeration growth promotion microbial ID etc.) and aseptic technique needed to perform EM in a GMP environment.
- Familiarity with regulatory guidance (FDA EU Annex 1 USP <61> <62> <85> <1116> etc.) and industry best practices.
- Excellent leadership communication and problem-solving skills.
- Experience with digital monitoring tools (e.g. ELLAB MODA LIMS) and quality systems such as Veeva is a plus.
- The ability to work and lead in a fast-paced environment manage priorities and maintain timelines for multiple projects is essential.
- Effective communication skills both verbal and written at all levels and across various functions.
Required Experience:
Senior Manager
Employment Type
Full-Time
Key Skills
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