DEPARTMENT: Quality Assurance
The Biosurgery Quality Assurance (QA) department is responsible for quality oversight of operations at the Sanofi Framingham Biosurgery facility. Biosurgery QA’s primary responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. Biosurgery QA is responsible for providing support and guidance to the Biosurgery Operations function in order to protect the safety, quality, and efficacy of Sanofi medical device 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.
POSITION OVERVIEW WITH KEY RESPONSIBILITIES:
The Associate Director Quality – Biosurgery QA serves as departmental the primary representative at the site providing daily operations quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs by representing QA Management during +QDCI and business meetings related to compliance activities. The Associate Director Quality also supports other Sanofi sites within the network regarding lot release and compliance and functions as the delegate Quality decision-maker on behalf of the Biosurgery Quality Director..
The Associate Director Quality serves as the primary Biosurgery Quality representative at the site for daily operations with direct interaction and collaboration with Manufacturing Operations, Quality Control, and Supply Chain to ensure business needs are met. As a delegate to the Quality Director, the Associate Director Quality interacts with external customers regarding lot release status and compliance topics.
As an active participant during internal and external audits/ regulatory inspections, the Associate Director Quality directly represents and addresses questions related to QA systems, documents, and decisions made. Leads in the preparation, execution, and follow-up for audits from regulatory agencies, notified bodies, customers, and Global Quality Auditors regarding product disposition decisions and Biosurgery Quality oversight functions. Furthermore is an active participant during Material Review Board (MRB) meetings.
A key function of the Associate Director Quality is to perform disposition of intermediates and finished goods and in this capacity is responsible for providing leadership to the QA team by assigning and coordinating tasks required to meet daily scheduled activities, tracking lot release status, and ensuring completion as scheduled. In this capacity, the Associate Quality oversees the departmental training program by developing training strategies for newly hired personnel, the continued progression and development of more junior team members, and ensuring a continuous state of safety and GMP training compliance. To ensure the necessary balance between team capacity and supply chain demand, the Associate Director Quality maintains the departmental capacity plan.
The Associate Director Quality will support the development of qualified staff to effectively carry out department functions. They will also provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
The Associate Director Quality may also act as an SME for lot disposition assessment of CCRs, generates CoA, represents the functional area in meetings and technical activities, acts as document owner for SOPs and maintains periodic reviews, conducts walkthrough inspections, functions as CAPA owner, provides expertise during procedure/SOP revision process and functions as DCR approver for department related SOPs and performs metric generation and reporting,
Additional Responsibilities include:
As a delegate of the QA Director, the Associate Director Quality runs the Daily Capacity Management (DCM) process, coordination of daily scheduling and assignments for the QA team members, providing experienced Quality decision-making, and providing timely escalation of critical issues to the QA Director.
Perform all aspects of lot issuance, lot review, and release process, ensuring compliance to the relevant site release SOP and corporate standard.
Quality review and approval of manufacturing process studies, method validations, and other complex technical documents.
Leads or supports cross-functional project teams.
Partner with manufacturing and support operations to ensure a culture of continuous compliance.
Conducts walk-through inspections
Perform various QMS trending/reporting functions, Failure Modes & Effects Analysis (FMEA)/risk team member as appropriate.
Represent QA in the investigation of lot-associated deviations.
Perform Gemba support and ensure timely execution of containment activities.
Approve non-conforming material discards.
Review and approve NRSRs (Non-Routine Sample Requests).
Challenges include being responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviations from decisions made by the Quality representative are escalated to QA/APU as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
Other activities as assigned
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and
delivery of all our products and services.
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
Coaching and mentoring QA personnel including QA Ops customers
Flexible and adaptable to changes and support business needs
Leading the Business
Sanofi's leaders are effective at operating in an evolving, complex, and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers
5 years of experience in a Quality role and/or with Quality Systems.
5 years experience leading people (direct reports or teams)
5 years experience with external agency cGMP regulations (FDA, EMA, etc.)
Strong computer, verbal, and written communication skills
Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations
Operations experience in one of the following areas: Quality Assurance or Quality Control, Manufacturing
6+ years of experience in a Quality role
Experience with Lot disposition
Experience with ERP systems
Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems
Demonstrated experience with change control, CAPA, and deviation quality systems including root cause analysis tools
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:
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.