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Sanofi Group Manager, Shop Floor QA - Vaccine in Pearl River, New York

Location: Pearl River, NY

Scope of role: Individual Contributor (no direct reports).

This is a New position in a growing team and a great opportunity for the right candidate to be part of a dynamic organization. Responsibilities to Lead and implement change to the organization by aligning to the Sanofi standards on the manufacturing floor from the Quality perspective.

Summary:

This Quality position ensures Quality Compliance oversight with cGMP, Regulatory and Internal requirements regarding the manufacturing, testing, and distribution of products through formal QA GEMBA/Audits, investigations, training and recommendations to procedures.

Quality oversight involves, but is not limited to: auditing of manufacturing, laboratory, warehouse, engineering areas for compliance, deviation support, documentation support, trending, risk assessments, and adherence to the program as documented.

The Manager of Shop Floor QA will evaluate and provide QA recommendations on all products, systems and issues that are/may be affected by regulatory or cGMP. Lead QA involvement in deviations and investigations and weekly site internal audit walk throughs. There is an expectation to spend a majority of their time on supporting the manufacturing operation from the quality perspective.

KEY ACCOUNTABILITY:

Quality Review of Shop Floor Documentation - 20% of time

  • Perform real time reviews of manufacturing batch records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.

  • Be present on the floor during batch processing

  • Perform consistent review of all logbooks on shop floor

  • Review all shop floor documentation for completeness and accuracy once off the floor

Shop Floor Walkthroughs - 20% of time

  • Perform monthly internal audit/Gemba walk through of manufacturing, QC, Engineering (Facilities) areas as assigned by DD, Product Quality

  • Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.

  • Make recommendations to department management regarding results of investigations and process improvements

  • Ensure facility is “inspection ready” at all times.

  • Support FDA & international regulatory bodies during site inspections.

Investigation Management - 20% of time

  • Manage weekly/monthly KPI’s related to deviations and CAPAs

  • Lead investigations, as needed

QA Oversight of Deviations and Change Controls - 25% of time

  • Initiate deviations as required

  • Provide guidance to resolve compliance issues and procedural errors in real time.

  • Collaborate with operations to a standardized template

  • Close minor deviations

  • Assist in change controls approval to proceed/closures

Additional Functions Assigned - 15% of time

  • First responder to address any non-routine events on shop floor

  • Quality review/release of engineering work order and preventative maintenance

  • Perform special projects as assigned by Deputy Director Product Quality

  • Team member of assigned project team(s). This includes, but is not limited to, review and approval of project related requirement documents.

  • Assist in audit – QA representation for tours as needed

CONTEXT OF THE JOB/MAJOR CHALLENGES:

The position requires intense concentration and visual examination of GMP documents. Data not entered right first time causes delay in product disposition to the market, potential loss of sales, potential recall, and/or customer complaints. The activities must be performed with high a level of quality/attention to detail in order to ensure quality products and meeting the needs of all customers. This position also requires experience and knowledge related to documenting robust deviations, investigations and CAPA’s. The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.

BASIC QUALIFICATIONS (Specific Degree & Duration of Experience required to be considered for this role):

  • Minimum Bachelor degree required, preferably in Science or Life Sciences AND 5-10 years’ experience in a cGMP controlled/ pharmaceutical industry ( preferably in a regulated Quality environment)

OR

  • An Advanced degree in Science/Life Sciences, if less than 5 years’ experience in a cGMP controlled/ pharmaceutical industry within a Quality environment

AND

  • 1-3 years’ experience working with Quality Systems.

  • Quality Assurance experience in a Pharma/Vaccine production facility.

  • Knowledge of vaccines/biologics products and associated technologies.

  • Previous experience with upstream processing of Drug Substance and/or Quality Control testing in a cGMP facility.

  • Ability to understand complex data, attention to detail, technical writing, excellent communication/interpersonal skills, excellent organizational and teamwork abilities, working knowledge of the cGMPs and regulatory requirements.

  • Experience in decision making, leadership, auditing and deviation investigations.

  • Ability to work on cross functional project teams.

  • Meet/Exceed project timelines/deliverables.

  • Software experience in Geode, LIMS, Trackwise, Phenix, Word and Excel preferred.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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