QA Principal Team Lead
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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 QA Principal Team Lead is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to cGMPs as well as being 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. The QA Principal Team Lead serves as a QA Operations representative at the site with direct interaction and collaboration with the manufacturing operations, facilities, engineering, and Quality Control departments. The QA Principal Team Lead is a primary contact for QA Operations during interactions with all other departments at the site to ensure that business needs are met by representing QA Management during +QDCI and business meetings related to compliance activities.
As a delegate of the QA Manager, the QA Principal Team Lead runs the Daily Capacity Management (DCM) process coordination of daily scheduling and assignments for the Compliance Specialists supporting the QA Management team providing experienced Quality decision making providing timely escalation of critical issues to QA Management.
Core Responsibilities include:
Perform all aspects of lot issuance, lot review and release process, ensuring compliance to the relevant site release SOP and corporate standards,
Ensures a constant state of departmental readiness for internal and external audits and inspections.
As an active participant during internal and external audits/regulatory inspections, the QA Principal Team Lead directly represents and addresses questions related to QA systems, documents, and decisions made regarding product disposition. Leads in the preparation, execution and follow-up for audits from regulatory agencies, notified bodies, customers and Global Quality Auditors.
Represent QA in the investigation of lot-associated deviations. Initiate, investigate and perform QA review of non-lot associated deviations.
Perform gemba support.
Execute containment activities
Approve non-conforming material discards.
Act as Site Coordinator and QA approver for change controls (CCRs).
Function as SME on input to quality decisions.
Conducts walk-through inspections
Partner with manufacturing and support operations to ensure a culture of continuous compliance.
Revise procedures/SOPs. Provide expertise during procedure/SOP revision process and function as DCR approver for Biosurgery APU related SOPs and PRs.
Perform various QMS trending/reporting functions, Failure Modes & Effects Analysis (FMEA)/risk team member as appropriate.
Function as team lead or represent QA as a primary contact on cross-functional project teams.
Quality review and approval of manufacturing process studies, method validations and other complex technical documents.
Approve and Release action notices.
Review and approve NRSRs (Non-Routine Sample Requests).
Assume leadership role in the training of new employees.
Perform quality inspections of intermediates and finished goods
Perform review of QC data.
Perform logbook review.
Provide on the floor (OTF) support to the operations department, including OTF support for critical operations.
Assess Building Management System (EMS) alarms and investigations
Challenges include responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviation 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
Master's Degree & 6 years of experience, Bachelor’s Degree in a scientific discipline and 8 years of experience, Associate's Degree and 9 years of experience or High School Diploma and 12 years of experience in a Quality and /or other CGMP related field
2 years of experience in a Quality role
Working experience in external agency regulatory audits (FDA, EMA, etc.)
Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations
Prior experience leading teams or projects
Strong computer, verbal and written communication skills
Operations experience in one of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation
Experience with Sanofi Manufacturing System (SMS) or comparable continuous improvement systems.
Strong computer, verbal, and written communication skills
Experience with root cause analysis tools
Demonstrated experience with change control, CAPA and deviation quality systems
6+ years experience in a Quality Assurance role
Technical writing skills
Effective time management, attention to detail, organizational skills, teamwork and collaboration
Capability in problem solving methodology
Experience participating in external agency inspection
Knowledge of regulatory enforcement trends
Ability to work independently
SPECIAL WORKING CONDITIONS:
Ability to gown and enter clean rooms
Ability to lift 10 lbs.
Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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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