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<p>Job Title: Third Party Manager</p> <p>Location: Framingham, MA</p> <p>About the Job</p> <p>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.</p> <p>The Third Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA BioCampus. Our focus is on ensuring excellence in quality standards and regulatory adherence in all external partnerships.</p> <p>The Third Party Manager provides leadership and strategic direction for the Third Party Quality Management team at the MA BioCampus. This role has indirect oversight of Third Party Management Specialists and is responsible for ensuring the team maintains high-quality standards and regulatory compliance in all external partnerships.</p> <p>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?</p> <p>Main Responsibilities:</p> <p>Team Leadership and Development:</p> <ul> <li></li><li></li></ul> <p>Provide mentorship, guidance, and technical support to Third Party Management Specialists</p> <ul> <li> <p>Facilitate professional development and training opportunities for team members</p> </li><li> <p>Establish performance metrics and conduct regular reviews</p> </li><li> <p>Foster a collaborative team environment focused on continuous improvement</p> </li></ul> <p>Strategic Program Management:</p> <ul> <li></li><li></li></ul> <p>Develop and implement strategic initiatives for Third Party Quality Management</p> <ul> <li> <p>Oversee the Supplier Change Notification (SCN) program</p> </li><li> <p>Lead the Quality Agreement Program strategy and implementation</p> </li><li> <p>Establish KPIs and metrics to measure program effectiveness</p> </li></ul> <p>Quality System Oversight:</p> <ul> <li></li><li></li></ul> <p>Ensure compliance with cGMP requirements and regulatory standards</p> <ul> <li> <p>Lead quality risk assessments for third party engagements</p> </li><li> <p>Oversee third party audits and quality investigations</p> </li><li> <p>Drive continuous improvement in quality management processes</p> </li></ul> <p>Cross-Functional Collaboration:</p> <ul> <li></li><li></li></ul> <p>Serve as the primary liaison between Third Party Quality and other departments</p> <ul> <li> <p>Represent the team in cross-functional meetings and initiatives</p> </li><li> <p>Collaborate with QC, Facilities, Manufacturing, and Supply Chain teams</p> </li><li> <p>Partner with Global Quality teams to ensure alignment with corporate strategies</p> </li></ul> <p>Regulatory Intelligence and Compliance:</p> <ul> <li></li><li></li></ul> <p>Stay informed of evolving regulatory requirements and industry best practices</p> <ul> <li> <p>Translate regulatory changes into actionable guidance for the team</p> </li><li> <p>Prepare for and participate in regulatory inspections</p> </li><li> <p>Develop strategies to address compliance gaps</p> </li></ul> <p>About You</p> <p>Leadership Qualifications</p> <ul> <li> <p>The ideal candidate will have strong leadership abilities, excellent communication skills, and a thorough understanding of pharmaceutical quality systems and third-party management.</p> </li><li> <p>Demonstrated ability to lead and develop a team of quality professionals</p> </li><li> <p>Experience in managing complex quality programs and initiatives</p> </li><li> <p>Strong decision-making skills with the ability to prioritize competing demands</p> </li><li> <p>Excellent interpersonal skills with the ability to influence without direct authority</p> </li><li> <p>Proven track record of driving continuous improvement and change management</p> </li></ul> <p>Basic Qualifications</p> <ul> <li> <p>Bachelor's degree in Life Sciences, Engineering, or related field.</p> </li><li> <p>Minimum 10 years of experience in pharmaceutical/biotech Quality with at least 5 years in Third Party Quality Management</p> </li><li> <p>At least 3 years of team leadership experience</p> </li><li> <p>Thorough understanding of cGMP requirements and pharmaceutical quality systems</p> </li><li> <p>Experience with supplier quality agreements, change management, and quality investigations</p> </li></ul> <p>Preferred Qualifications</p> <ul> <li> <p>Advanced degree preferred</p> </li><li> <p>Experience with Veeva quality management system</p> </li><li> <p>Strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia)</p> </li><li> <p>Experience in LEAN methodologies and process improvement</p> </li><li> <p>Experience in developing and implementing quality metrics and KPIs</p> </li><li> <p>Strong presentation and facilitation skills</p> </li></ul> <p>Special Working Conditions</p> <ul> <li>Ability to gown and gain entry to manufacturing and warehouse areas </li></ul> <p>Why Choose Us?</p> <ul> <li> <p>Bring the miracles of science to life alongside a supportive, future-focused team.</p> </li><li> <p>Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.</p> </li><li> <p>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</p> </li><li> <p>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.</p> </li></ul> <p>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.</p> <p>#GD-SG</p> <p>#LI-GZ</p> <p>#LI-Onsite</p> <p>#vhd</p> <p>Pursue progress, discover extraordinary</p> <p>Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.</p> <p>At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.</p> <p>Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!</p> <p>US and Puerto Rico Residents Only</p> <p>Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.</p> <p>North America Applicants Only</p> <p>The salary range for this position is:</p> <p>$108,750.00 - $157,083.33</p> <p>All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.</p>
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