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Job Title: QA Operations PCU Lead, Operations Support

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Biologics facilities. QA’s main responsibility is to ensure adherence to CGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities.  Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations functions in order to protect the safety, quality and efficacy of Sanofi’s products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• The QA PCU Lead, Operations Support is responsible for providing quality support and direction to Engineering & Maintenance, Quality Control and other campus support functions to ensure continued compliance to CGMPs and quality systems.

• This role leads a team in QA Operations to provide quality/compliance support to MaBiocampus facilities.

• The QA PCU Lead, Operations Support serves as a QA Operations representative at the site with direct interaction and collaboration with the Engineering & Maintenance, Quality Control and other support departments. 

• The role also supports other Sanofi sites within the network regarding quality topics and compliance.    

• The QA PCU Lead, Operations Support is a primary contact for QA Lot Disposition and Manufacturing during interactions with all other departments at the site to ensure that business needs are met related to compliance and intermediate lot release activities.

• As an active participant during internal and external audits/regulatory inspections, this role directly represents and addresses questions related to QA systems, documents, and decisions made regarding intermediate product disposition, deviations, and batch record adherence for areas of responsibility.  

• The QA PCU Lead, Operations Support may also routinely participate in Material Review Board (MRB) meetings making product disposition recommendations, Deviation Review Board Meetings, and CDI governance.

• This role is responsible to develop and maintain appropriate systems to ensure continuing team performance and communication, such as +QDCI, project, and staff meetings, providing updates of department activities and project statuses to senior management.

Staff Management

• Select, develop, and motivate qualified staff to effectively carry out department functions.

• Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.

• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action.

• Provide direction, assign tasks, and manage team(s).

Budget

• Provides input into the department budget.

Department Management

• Establish, maintain and report applicable department or organizational metrics.

• Accountable for project completions and achievement of compliance goals

• Interact with Project Teams and cross-functional groups as they impact the quality operation.

• Address and/or escalate compliance problems and issues.

• Additional Responsibilities including oversight of:

• Oversight of the review and approval of records in a timely manner.

• Timely issue escalation to Quality Assurance senior management and crossfunctional support teams.

• Ensure effective interaction with other departments on matters related to investigation and intermediates in particular Quality Control, Manufacturing, Planning, Regulatory Affairs, and Manufacturing Science and Technology.

• Develop and maintain appropriate systems to ensure continuing team performance and communication, such as +QDCI, project, and staff meetings, providing updates of department activities and project statuses to senior management.

• Provide quality expertise and oversight to the Manufacturing and support operations.

• Partner manufacturing and supports areas with inspection readiness.

• Comply with requirements from Sanofi's Safety Program including Health and Safety regulations and OSHA requirements.

• Provide quality assurance oversight for management tools, systems, and documentation (SOPs, MBRs, OJTs).

• Identify opportunities and champion positive change to improve quality assurance processes and practices.

• Partner with SMS Organization to drive business process improvements through SMS initiatives and programs.

• Develop and manage delivery of department and team member goals which are aligned with business objectives.

About You

Basic Qualifications

• Masters Degree and 6 years' experience, Bachelor’s Degree and 8 years experience, Associate’s Degree and 10 years' experience, or High School Diploma and 12 years' experience in a Quality and /or other cGMP related field

• 5 years of experience in a Quality role and/or with Quality Management Systems.

• 5 years experience leading direct reports

• 5 years experience with external agency cGMP regulations (FDA, EMA, etc.)

• Strong computer, verbal, and written communication skills

Preferred Qualifications

• Operations experience in one of the following areas: Manufacturing, Quality Assurance, Facilities and Maintenance, or Quality Control

• Management experience in one of the following areas: Manufacturing, Quality Assurance, Quality Control

• 6+ years experience in a Quality role

• Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems

• Experience with ERP and Electronic Batch Record systems

• Demonstrated experience with change control, CAPA and deviation quality systems

• Experience training and developing employees

• Strong Technical writing skills

• Effective time management, attention to detail, organizational skills, teamwork and collaboration

• Capability in problem solving methodology

• Experience participating in external agency inspections

• Knowledge of regulatory enforcement trends

• Ability to work independently

Special Working Conditions

• Must be able to gown and work in a clean room environment.

Why Choose Us?

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.