Senior Manager, Quality Assurance Contamination Control and Sterility Assurance (Hybrid)

Job Description

The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for contamination control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal manufacturing sites to support the maintenance of critical cGMP contamination control activities and provide technical support for the overall contamination strategy and facility monitoring programs.

The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs. In addition, the successful candidate will be experienced in the fields of sterility assurance, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems.

This role will report to the Senior Manager, Quality Assurance Contamination Control and Sterility Assurance within the Vertex Cell and Genetics Therapies QA group.

Key Duties and Responsibilities:

• Driving Sterility Assurance:

• Maintain and support the site Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and Global GMP guidelines.
• Conducting risk assessments for aseptic processes, environmental monitoring, facilities and other interrelated systems to mitigate contamination risks.
• Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
• Establish and maintain analytics and KPI reporting methods for site Contamination Control performance.
• Support review and approval of APS Process-Specific Master Batch Records (MBRs)
• Consult as SME for Deviations during APS execution

• Oversight of Environmental Monitoring and Contamination Control:

• Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
• Investigating out-of-specification results (deviations) in environmental monitoring, manufacturing, identifying root causes, and implementing corrective actions to prevent recurrence.
• Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.
• Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.

• Sterility Related Validation:

• Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during execution, report reviews and approvals.
• Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness.
• Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.

• Leadership and Collaboration:

• Support a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.
• Support/lead monthly contamination control committee providing technical analysis regarding EM performance and system health.
• Working cross-functionally with Quality, Quality Control, Manufacturing, Validation and Engineering teams to ensure alignment on sterility assurance requirements.
• Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.
• Lead or support quality investigations, risk assessments, and CAPA development. Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies.
• Documentation and Reporting:
• Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports.
• Tracking and reporting contamination control performance metrics to identify areas for improvement and enhance contamination control strategies.
• Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.
• Support inspection readiness plans and interact with regulatory agencies during inspections on contamination control related subject matter.
• Assess Impact to CCS as the functional area owner per Change Management

• GMP Qualification

• Supporting the qualifications of isolators, and other clean air equipment.
• Supporting the qualifications of cleanrooms including aspects such as Cleanroom Recovery, Airflow Visualization and Environmental Classification.
• Supporting the qualification of critical utilities including Compressed Gas(s) and WFI systems.

Education and Experience:

• *Educational Background: Minimum of a Bachelor's degree is preferred in Microbiology, Biotechnology, or a related discipline.

  *Work experience: 6-10 years of sterility assurance/contamination control or GMP experience (Commercial preferred).

  *Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.

  *Aseptic Process Expertise:

  o Proven experience in contamination control strategies

  o Proven experience with clean air equipment, environmental monitoring, and aseptic processing simulations.

  *Leadership Skills: Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.

  *Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions.

  *Technical Proficiency: Proficient in the use of contamination control tools, monitoring systems, including LIMS, Excel, and project management software.

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you canchoose to work:

1.Hybridand work remotely up to two days per week;or select

2.On-Site andwork 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com