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Manager, Quality Batch Release US (Swiftwater, PA) - Vaccine

Swiftwater, Pennsylvania

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Overview

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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Responsibilities

The Product Quality (PQ) Manager will operate under flexibility to perform the necessary activities to ensure compliance requirements and manufacturing/ release schedules are met.  The PQ Manager supports five core activities:  Preparation & Certification of Working Documents, Quality Review of Batch Records, Batch Disposition, Quality Review of Lot Release Protocols, Compliance and Performance

Quality Review of Batch Records:

  • Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations.

  • Complete all required system transactions associated with the batch record review process.

  • Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material.

Disposition of Batches:

  • Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition.

  • Verify CBER release is received (if applicable) prior to batch disposition.

  • Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition.

  • Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch.

  • Complete all required system transactions associated with the batch disposition process.

  • Act as delegate to the PQ BR Deputy Director to provide approval to ship to external manufacturers, as assigned

Quality Review of Lot Release Protocol (LRP):

  • Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority.

  • For licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country.

  • Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity.

Preparation & Certification of Working Documents:

  • Prepare batch records from master documents in the electronic document management system according to procedure

  • Ensure right first time preparation and completion of required documentation via electronic system (SAP and/or TrackWise)

  • Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule.

  • Certified prepared batch records to ensure completeness and accuracy in accordance to procedure.

  • Provide metrics in support of +QDCI board meetings.

Compliance and Performance:

  • Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities.

  • Investigate deviations, as assigned.

  • Perform special projects as assigned by PQ Deputy Director.

  • Team member of assigned project team(s).  This includes, but is not limited to, review and approval of project related requirement documents, IS Change Requests, LabWare MDM forms, protocols, reports, user and functional specifications, etc.

  • Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements.

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.  Certification of working documents, review and release of media reagent and review of lot release protocols are measured for productivity and quality.  The activities must be performed with high level of quality to ensure quality and meet the needs of our customers.   The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act.

Freedom to Act, Level of Autonomy

The job holder is expected to work independently with a level of autonomy and authority for decision making within the defined scope of the job that is necessary to drive process improvements, with compliance to internal and external policies and procedures and current GMPs.

Basic Requirements:

  • Minimum Bachelor degree, preferably in Science or Life Sciences, with at least 2 years in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment.

  • Knowledge of cGMP (US, Canada, Japan, Europe). 

Competencies of the Successful Candidate:

  • Excellent analytical, communication, interpersonal skills, as well as strong organizational and teamwork abilities. 

Preferred Qualifications:

  • Experience in SAP, Documentum, LIMS, and Trackwise is highly 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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