Director - Quality - Sanofi - Allston

Job description
The Contamination Control team reports directly to the site quality lead. The mission of this organization is to provide microbiologic expertise, investigative services and contamination control leadership ensuring that the site maintains robust aseptic control over the manufacturing environment.

Consent Decree Duties:

Member of all Site Contamination Control Teams
Provides a link to Site CD implementation activities

Actively involved in system design decision making and team meetings – insures systems are simple, sustainable, robust, and compliant
Key participant in meeting consent decree work plan penalty milestones timelines for EM, bioburden, and critical utilities monitoring work plans
Key participant in working to resolve issues to the Site Contamination Control Lead
Helps to coordinate the execution of the environmental monitoring risk assessment and/or EQ studies to the CC site lead, Quality Assurance, the Environmental Action Committee (EAC) and senior leadership
Coordinate work plans with Global Cell Banking (GCB) and other contamination control teams at Framingham to ensure consistency of approach
Work with the facilities and Equipment Project Upgrade Team to discuss the results of facility walkthroughs for installation and relocation of critical utility sampling sites
Build consensus, across functional areas and obtain stakeholder agreement for Work Plan implementation
Monitor revised processes and metrics to evaluate effectiveness of work plan implementation and continued sustainability
Coordinate efforts with of CD teams and Contamination control team leads
Work with the Viral Assessment Risk Management team to insure interoperability with Contamination Control CD Team

Site Duties
Leadership to Environmental Action Committee (EAC)
Communication to senior management on all issues relating to contamination control
Serves as Site Biosafety Officer and member of the Corporate Biosafety Committee
Participates in All site leadership management reviews
Investigation and impact assessment following microbiologic excursions
Ensure that all relevant Trending for environmental monitoring, bioburden and critical utilities monitoring is accurate, timely and actionable
Ensure all relevant procedures including timely production of trending EAC minutes and quarterly trending reports in within stated timeframes and compliant IAW approved procedures
Microbiological Assessment that supports lot release
Manages viral risk mitigation response and plan
Provides Microbiology education programming and awareness to the site
Provides technical guidance, professional development, and supervision to team members
Ensures compliance with Genzyme corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring
Provides leadership in conducting risk assessments pertaining to contamination controlProvide ALF interface and coordination with contamination control activities occurring in Framingham

Basic Qualifications
Strong microbiology background or Life Science technical background
Minimum 10 years of experience in pharmaceutical manufacturing with a minimum of 8 years’ experience in biopharmaceuticals/biotechnology applications
8 years in management or higher roles

Preferred Qualifications
Good leadership skills
Analytical, problem solving, communication skills

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