Third Party Management Specialist
Synthorx
Job Title: Third Party Management Specialist
Location: Swiftwater, PA
About the job:
As a Third Party Management Specialist, you will ensure the quality and compliance of our pharmaceutical third-party partnerships by evaluating, qualifying, and certifying suppliers based on their quality systems and capabilities. You will develop quality agreements, establish audit programs to assess GMP/GDP compliance, and drive continuous improvement initiatives while identifying and mitigating risks. Your role involves resolving quality issues, managing corrective actions, and maintaining proper documentation of all third-party activities. Success requires experience in pharmaceutical quality management systems, strong analytical and communication skills, audit expertise, and project management capabilities to oversee multiple quality initiatives while ensuring regulatory excellence and patient safety.
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.
Main Responsibilities:
Evaluating and qualifying new Third Party and when applicable, certifying Third Party based on their quality systems, capabilities, performance history and Quality Control expertise.
Ensuring that all third-party activities comply with relevant legal and regulatory requirements (e.g., QSMP).
Ensuring proper documentation and record-keeping of all third-party quality activities and communications.
Driving continuous improvement initiatives with Third Parties to enhance product quality and process efficiency.
Developing and maintaining quality agreements and Technical Specifications (PTS, STS) with Third Parties, outlining quality expectations and responsibilities.
Establishing an annual audit program of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and internal documents.
Identifying and mitigating risks associated with Third Parties through risk assessments and implementation of corrective actions.
Ensuring the resolution of quality issues related to Third Parties, including audit observation, deviations, non-conformances, and Third Party complaints as well as supporting customer complaints.
Monitoring the progress and timely implementation of any CAPA addressing quality issues or supporting continuous improvement
About you:
Bachelor's degree (Life Sciences, Business Administration or related fields - preferred)
A combination of education and experience will be considered.
1+ years of experience in third-party quality management systems, QA or related areas in the pharmaceutical industry.
Experience using Veeva.
Experience in quality management systems in the pharmaceutical industry.
Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality and compliance.
Strong verbal and written communication skills to effectively interact with third-party suppliers, internal teams, and regulatory bodies.
Proficiency in conducting thorough and effective audits of third-party suppliers to ensure compliance with quality standards and regulations.
Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective actions.
Strong project management skills to oversee multiple quality initiatives, manage timelines, and ensure successful completion of projects
Fluent in English, both written and spoken.
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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Pursue progress, discover extraordinary
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.
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.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
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.
North America Applicants Only
The salary range for this position is:
$67.500,00 - $97.500,00All 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.