Principal Compliance Specialist
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The Quality Assurance (QA) Operations department is responsible for quality oversight of operations at Sanofi Framingham Manufacturing 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 Principal Compliance Specialist – QA Lot Disposition 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 training and technical support serving as a Subject Matter Expert (SME) to the QA Lot Disposition team.
- The Principal Compliance Specialist serves as a QA Lot Disposition representative at the site with direct interaction and collaboration with the Manufacturing Operations and Quality Control departments.
- The Principal Compliance Specialist also supports other Sanofi sites within the network regarding lot release and compliance.
- The Principal Compliance Specialist is a primary contact for QA Lot Disposition 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 and lot release activities.
- As an active participant during internal and external audits/regulatory inspections, the Principal Compliance Specialist directly represents and addresses questions related to QA systems, documents, and decisions made regarding product disposition.
- The Principal Compliance Specialist for QA Lot Disposition generates CoA, lot genealogies, and prepares lot packet disposition documentation in support of lot release, performs QC assay and logbook reviews, represents the functional area in meetings and technical activities, acts as document owner for SOPs and maintains periodic reviews, actively supports the QA Operations team by providing technical support, ensures all safety requirements are being met within the department, , conduct log book audits against compliance requirements, review CV related documentation against specification, supports cross-functional internal audit activities and conducts walkthrough inspections, function as CAPA owner, provides expertise during procedure/SOP revision process and functions as DCR approver for department related SOPs and PRs, performs metric entry, functions as document owner, participates in Material Review Board (MRB) meetings, maintains a high level of personal compliance to the required standards, and partners with manufacturing and Quality Control to ensure a culture of continuous compliance Challenges include responsible for 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
- Masters Degree and 4 years experience, Bachelor’s Degree and 6 years experience, Associate’s Degree and 8 years experience, or High School Diploma and 10 years experience in a Quality and /or other cGMP related field
- 2 years of experience in a Quality role.
- Knowledge in external agency regulations (FDA, EMA, etc.).
- Strong computer, verbal, and written communication skills
- Operations experience in one of the following areas: Quality Assurance or Quality Control
- 4+ years experience in a Quality Assurance 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
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.
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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