QA Principal Compliance Specialist, Operations

Job Title: QA Principal Compliance Specialist, Operations

Location: Framingham, MA

About the job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as [Job Title] within our [Team Name], will be to [summary of opportunity].

Department Description

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

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.

About you

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