Senior Engineering Compliance Specialist

Job Title: Senior Engineering Compliance Specialist

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

The Facilities Compliance Team is responsible for managing change controls, CAPAs and deviation intake and closure across GMP activities in the following areas - Metrology, Engineering, Facilities, Utilities, Validation and Capital Projects. The responsibilities of the team primarily extend to owning deviations relating to facilities, equipment and utilities and their associated systems. The team is also responsible for coordinating resources across other teams in the extended Facilities and Engineering group that own or have input to deviation closure and CAPA creation. The team interfaces closely with quality functions such as QA, QC, Contamination Control and QE to ensure coordination of timely closure. They work with the Deviation Quality System Owner to ensure Facilities and Engineering are aligned with the relevant compliance standards and have an active continuous improvement and risk mitigation plan associated with our deviation intake. 

The Compliance Specialist is responsible for developing mechanisms to ensure all aspects of facilities and engineering are managed to compliance.  They also develop and maintain key metrics to drive improvements throughout the facilities organization and partner with the Facilities & Engineering Operation staffs where/when necessary to drive improvements.

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?

Main Responsibilities:

Participate on a team of individuals to support compliance in the following Facilities and Engineering Work Streams:

·         Change Controls, CAPAs, Deviations, Effectiveness Checks

·         Engineering Document Management

·         Work Orders

·         Periodic Reviews

·         Engineering and C&Q Lifecycle Documents

• Investigate Quality Events, propose and implement CAPAs, CCRs, Effectiveness Reviews, and regulatory commitments

• Perform periodic reviews of documents in order to maintain compliance and support document revisions

• Support regulatory and internal inspections/audits

• Maintain a high level of personal compliance to the required standards

• Partner with Quality and other departments/leadership to ensure a culture of continuous Compliance

• Review quality systems to identify opportunities and implement solutions for continuous Improvement

• Support training of new and experienced employees to ensure compliance with GMPs and Standard Operating Procedures

• Lead small project teams

• Ensure projects are completed on schedule with results on time

• Manage project related records through collaboration with the teams performing project related work

• Identify opportunities to improve processes and practices to increase compliance Readiness

• Comply with requirements from Sanofi's Safety Program including Health and Safety regulations and OSHA requirements

• Adhere to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.

Delivering to Customers

• Genzyme’s leaders understand patient and customer needs and build relationships as required to meet manufacturing goals.  They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance

About You

Basic Qualifications:

• Bachelor’s degree in Business, Engineering, or a related field with a minimum of 3 years of relevant experience, or 5 years of relevant experience in lieu of a degree.

• 2+ years of work experience in a cGMP environment

• Experienced in troubleshooting, investigation, root cause and risk analysis in a CGMP environment

• Experience writing and investigating deviations

Preferred Qualifications

• Experience within a manufacturing environment including quality systems, plant equipment, utilities and associated systems and processes

• Experienced facilitating meetings

• Experienced working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation

• Familiarity with Deviation Management Systems (i.e. TrackWise).

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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