QC Manager-Waltham, MA
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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 of 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 Manager of QC & Stability QATS within Specialty Care External Supply Quality provides GxP oversight for CLOs used in product release and stability testing; support method transfers, qualifications, and analytical lifecycle management, as well as management of supply of critical reagents and controls.
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
Engage in the 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
Responsible for 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 programs.
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 the 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 stable 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, forecast demand (quantity) and implement assay controls, critical reagents, and reference standards at testing sites
Maintain a 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
Frequent inter-departmental, inter-organizational, and external interactions
Reviews and compiles data for 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 and planning of analytical purchase orders for CLO testing activities and reagents, as well as any other planned analytical activities
BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical/biotechnology industry.
Demonstrated success in working cross-functionally in a matrix organization; minimum 4 years experience within a Quality role.
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.
OTHER SKILLS/ COMPETENCIES:
Possess strong organizational skills with the ability to multi-task and coordinate multiple activities in parallel.
Excellent oral/written communication, computer, presentation, and skills.
Manage through ambiguity, work independently and prioritize workload with minimal direction
Exude a passion for relationship building both inside and outside the company
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
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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