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Associate Director QC & Stability

Waltham, Massachusetts

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

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Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. SCES Q staff interact with functional units within Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.

  • SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.

  • SCES Q is based in Waltham, MA, Frankfurt, Germany and Ghent, Belgium.

  • SCES Q personnel may also be located remote or on-site at CMOs acting as a Person-in Plant.

The Associate Director of QC & Stability Quality Assurance Technical Services (QATS) – Specialty Care External Supply Quality supports the management of a team of quality experts responsible for supporting GxP activities related to the outsourced manufacture and testing of clinical/commercial drug substance and drug product and ensuring compliance with the Quality Management System (QMS), industry practice, and regulatory requirements. The individual works within the Quality organization and oversees Stability, Quality Control and Analytical Method Transfers (AT) activities as well as performing review and approval of technical documents.

Core Responsibilities:

  • Collaborate with senior management, peers and team to establish GxP priorities that are aligned with business objectives

  • Work with internal/external project team members to incorporate the appropriate elements of quality, equipment and production into QA/QC strategies

  • Drive execution of major GxP projects and ensure adherence to schedule, e.g. technology transfers, process performance qualifications (PPQ), stability programs, global regulatory submissions, annual product reviews, implementation of quality system applications

  • Provide GxP oversight for CLOs used in product release and stability testing; ensure trained resources available to support method transfers, qualifications, and analytical lifecycle management, as well as management of supply of critical reagents and controls. Responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.

  • Manage sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments and manage qualified materials program. Coordinate/Lead multiple site/global projects and represent QATS across organizations.

  • Manage the operation of Stability and Quality release testing programs across parts of a multi-product portfolio, managing timelines to meet corporate goals. Generate/ review and approve release Certificate of analysis from external testing results, assuring compliance to internal specifications.

  • Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA;

  • Contribute to stability and quality sections of Annual Product Review Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports

  • Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews

  • Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites Maintain list of approved test sites per product, methods performed/site, regulatory approvals per testing site

  • Maintain department and project metrics, as appropriate. Perform Sanofi oversight of procedure and document changes at CLOs.

  • Represent Sanofi Quality as project lead for projects at CLOs, as assigned. Participate in routine internal and external Operations Meetings Oversee and ensure effective interaction with other departments on GxP matters, in particular: Manufacturing Operations, Regulatory Affairs, Manufacturing Sciences and Technology, Supply Chain

  • Support resolution of complex Quality Assurance issues, working closely with internal/external cross functional teams, e.g. provide subject matter expertise to deviations and investigations and communicate impact to quality operations, drive closure and implementation of effective CAPAs in accordance with targets

  • Ownership of key performance indicators related to area of responsibility

  • Partner with Lean Organization, as needed Interface with external parties as required, e.g. regulatory authorities, vendors

  • Maintain an external network of expertise and represent the Site and/or Sanofi in professional organizations

  • Comply with requirements from Company Safety Program, including Health and Safety regulations and OSHA requirements

Other Responsibilities:

  • Frequent inter-departmental, inter-organizational and external interactions

  • Reviews and approves CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed

  • Support the development and management of quality agreements between Sanofi and internal/external parties

  • Financial management of analytical purchase orders for CLO testing activities and reagents

Basic Qualifications

  • BS/MS in a scientific discipline with a minimum of 10 years of experience in the pharmaceutical /biotechnology industry.

  • Demonstrated success in working cross functionally in a matrix organization;

  • Minimum 4 years’ experience in the Biotech/Pharmaceutical industry Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers);

  • LIMS experience preferred.

  • In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge

  • Effectively within a team/project environment.

  • Demonstrate leadership capabilities, but also the ability to actively listen and influence in a matrix organization.

Preferred Qualifications:

  • Advanced degree is preferred, along with experience ideally working with external partners (e.g. contract laboratories and suppliers);

  • Broad knowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory requirements (e.g. GMP, GDP, ICH)

  • In-depth understanding of quality and regulatory systems and management tools

  • Ability to coordinate and lead diverse teams in evaluation of GxP quality systems

  • Problem solving, technical writing and verbal communication skills - Clearly conveys information and concepts/principles

  • Ability to multi-task effectively

  • Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion

  • Experience with using operational excellence tools to drive continuous improvement.

Ability to travel up to 10% - primarily domestic - is required

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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