QA Principal Team Lead

Job description

POSITION OVERVIEW

Department Description

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 function 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.

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 tasks, tracking intermediate lot release, and addressing Quality requirements by delegating activities to Compliance Specialists and ensuring completion.
·  The Pr QA 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 Pr Team Lead also supports other Sanofi sites within the network sharing best practices for QA on the floor and Compliance.
·  The QA Pr 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 an active participant during internal and external audits/regulatory inspections, the QA Pr Team Lead directly represents and addresses questions related to QA systems, documents, and decisions made regarding product disposition.
·  The QA Pr 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.
·  Following the completion of daily leadership activities for the shift, the QA Pr Team Lead performs batch record and logbook review, approves
·  Change Controls related to batch record revisions, provides Quality Assurance on the floor (QAOTF) support for operations, issues action notices, conducts log book audits, conducts safety inspection and compliance audits, review of Cleaning Verification documentation, performs release of intermediate drug substance steps, supports cross-functional internal audit activities, provides expertise during procedure/SOP revision and DCR approver for SOPs/PRs, reviews Quality Critical Alarms, approves Non Routine Sample Requests, approves
·  change requests within LIMS, performs metric entry, issues paper batch records and logs, participates in Material Review Board (MRB) meetings and functions as a CAPA and document owner as required. Writes deviation investigations (Minor/Major/Critical) in support of QA and other departments on site as needed as well providing Deviation Gemba, Containment, and QA
·  Review responsibility.
·  Active participant and facilitator during the Deviation Governance meetings to improve the consistency within the Deviation and CAPA Quality Systems.
·  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 Operations Management, QA Director or the Quality Site Head as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
·  Additional activities as assigned

Leadership Qualifications

N/A

Basic Qualifications

·  Master's Degree & 7 years of experience, Bachelor’s Degree and 8 years of experience, Associate's Degree and 11 years of experience. or High School Diploma and 13 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

Preferred Qualifications

·  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 inspections
·  Knowledge of regulatory enforcement trends
·  Ability to work independently

Special Working Conditions

·  Ability to gown and gain entry to manufacturing and Quality Control area
·  Ability to lift 10 lbs

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.