Job Description:
Job Title: Quality Engineer Principal
Location: Framingham, MA
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 Quality Assurance Validation (QAV) department reviews and approves validation lifecycle documents, procedures, and technical reports related to (1) facilities, equipment, utilities, (2) cleaning, (3) processes, (4) analytical methods and equipment, (5) requalification, (6) sterilization, and (7) computer systems. QAV provides leadership, direction, and oversight for the MA BioCampus site validation program and is responsible for ensuring inspection readiness in alignment with regulatory compliance requirements, current industry standards, and Sanofi directives, standards and guidance.
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:
- Demonstrates strong leadership qualities and embodies Sanofi's core leadership principals
- Performs timely and complete QA review and approval of validation lifecycle documents and determines interrelated impacts to processes and systems. Ensures completeness, timeliness and accuracy of documentation such as engineering studies, validation protocols/nonconformances/reports, technical reports, engineering drawings, and MBRs/SOPs.
- Participates in Community of Practice discussions to share best practices and raise opportunities for simplification and harmonization
- Partners with project teams to develop the implementation strategy and change control approach for complex projects with validation impact
- Performs validation assessments for change control requests that comply with Sanofi and Biologics Quality standards, procedures and guidance
- Leads or participates in gap assessments against Sanofi and Biologics Quality directives/standards and authors gap remediation plans
- Authors or reviews validation section of annual periodic product reviews
- Proactively identifies compliance risk and presents to cross-functional site risk review team or quality council, as appropriate
- Applies Sanofi Manufacturing System (SMS) tools to daily ways of working in order to support a culture of continuous improvement
- Supports external regulatory inspections through consultation with other Subject Matter Experts and direct interaction with investigators for requests within area of expertise. Leads or supports execution of CAPA for external regulatory commitments.
- Participates in formal risk assessments
- Demonstrates 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 of our products and services. This includes:
• 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.
About You
Basic Qualifications:
- Bachelor's degree in Science or Engineering and a minimum of 9 years' experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years' experience working in a regulated, cGXP environment
- Operations experience in one or more of the following areas with demonstrated knowledge of the validation lifecycle: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Computer Systems/Automation
- Demonstrated knowledge of cGXP regulations and guidance
- Excellent technical writing skills
- Direct experience with change control and CAPA quality systems
Preferred Qualifications:
- Experience with LEAN Manufacturing (problem solving/use of LEAN tools) or comparable continuous improvement systems.
- Experience with root cause analysis tools and gap identification.
Special working conditions:
- Ability to gown and gain entry to manufacturing areas
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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