Quality Third Party Manager

Job Title: Quality Third Party Manager

Location: Swiftwater, PA 

Hours:

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. 

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:

• 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 Specification (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 observations, deviations, non-conformances, and Third-Party complaints

• Monitoring the progress and timely implementation of any CAPA addressing quality issues or supporting continuous improvement

• Managing the Quality Third Party team and ensuring their proper qualification for their activities

As a member of the Community of Practices (CoP) of Quality Third Party and Third-Party Audits:

Accountable for:

• Implementing the process and tool at the local level in line with the standardized and harmonized approach, including communication, change management, as appropriate.
• Responsible for:
• Being the "Voice of Customer"
• Providing feedback on the roadblocks and difficulties met related to the CoP area supported
• Providing return on experience on inspection, assessing the CoP area supported.
• Proposing evolution for simplification and harmonization of the process and tool.
• Sharing successes and best practices with other sites.
• Contributing to the objectives set via the CoP roadmap.
• Skills and Knowledge:
• Having the appropriate training and expertise in the CoP area supported.
• Good capability of communication
• English speaking technical skills

​Job Requirements:

Experience

• Bachelor's degree

• 5 years of experience in third-party quality management systems in the pharmaceutical industry

• Experience using Veeva

Technical Skills

• 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 the successful completion of projects

Language

• 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 a 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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