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Compliance Specialist III (Manufacturing/Quality)

Location: Framingham, Massachusetts
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Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. 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 is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Principal Compliance Specialist may also be responsible for providing leadership to the QA team in the absence of the manager.
Core Responsibilities include:
Provide Gemba Support
• Function as shift lead including developing junior employees
• Perform batch record review
• Perform review of column packing and qualification records
• Review and sign-off on manufacturing supervisor notes
• Review and approve CRs related to EBRs (as applicable)
• Function as SME on challenges related to production requiring a quality input
• Non-conforming material discard
• Perform log book review
• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
• Issue action notices and conduct affiliated provisional release
• Conduct log book audits against compliance requirements
• Review CV related documentation against specification
Perform Bulk Raw Material Release
• Perform media / buffer and intermediate release
• Perform release of Cell Banks for forward processing (as applicable)
• Support cross-functional internal audit activities and conduct walkthrough inspections
• Function as department lead for internal audits
• Function as CAPA owner
• Execute containment activities
• Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
• Function as document owner as needed
• Maintain a high level of personal compliance to the required standards
• Partner with manufacturing and support operations to ensure a culture of continuous compliance
• May provide training to new employees
• Review of Quality Critical Alarms and NRSR
• Initiate and investigate and QA review deviations
• Provide off-hour support for batch record and log book issuance
Represent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA).
• Function as back-up for QA Manager
• Other activities as assigned
* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

Leadership Qualifications

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.
This includes:
• 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

Basic Qualifications
Master's Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, Associate's Degree and 8 years of experience, or a High School Diploma and 10 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.
• Knowledge in external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills.
• Experience in quality systems.
• Experience in leading cross functional teams.
• Experience with Trackwise or equivalent system.
• Proficient in Microsoft Office.

Preferred Qualifications
• Bachelor’s degree in a scientific field with 6+ years of experience in a Quality and / or cGMP environment.
• 4+ year’s experience in a Quality Assurance role.
• Experience in bio-pharmaceutical industry.
• Capable of analyzing trends and metrics that lead to improvement.
• Strong technical writing skills.
• Effective time management, attention to detail, organizational skills, teamwork and collaboration.
• Significant capability in problem solving methodology.
• Experience working in an environment of operational excellence.
• Experience training and developing employees.
• 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 areas
• Ability to work a 12-hour rotating shift and every other weekend, including some holidays
• Ability to lift 10 lbs.

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