Senior Manager, Quality Management

SERVIER MONDE

4d • $141,000 - $161,000 • Remote

About The Position

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision. Candidate ProfileRole Summary
The Sr. Manager, Quality Management, reporting to the Director, US Regulatory Affairs and Quality Management, will support the US operational compliance with quality standards. Additionally, the role is responsible for quality document (QD) management, conducting gap assessments, proposing process changes, and leads the development of standard operating procedures (SOPs) and associated training.

Requirements

• Bachelor’s degree required, preferably in a scientific, healthcare, or business-related field
• 5+ years of professional experience in developing and maintaining quality systems and creation of standard operating procedures
• Demonstrated understanding of GxP and ability to practically apply them internally
• Independent decision making with a high degree of initiative
• Detail-oriented with strong organizational and time management skills
• Knowledgeable in pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation
• Excellent communication and interpersonal skills, with a team-oriented mindset and ability to manage multiple tasks

Responsibilities

• Collaborate cross functionally to ensure compliance with quality documents, including standard operating procedures (SOP) and department working practices for the US, as identified with Medical Leadership
• Review and approve local deviations, investigations, CAPAs, and change records, including providing quality management guidance
• Oversee Servier’s audit program, including audit preparation, coordination, execution, participation in the review of audit reports, and follow up to any findings
• Monitor new and updated Global SOPs for applicability to US quality documents
• Manage the US training matrix for quality documents
• Maintain and evaluate quality metrics, including time-based metrics around Change Controls, Deviations, CAPA, and complaint management.
• Responsible for maintaining local quality infrastructure in the US to ensure compliance with FDA regulations

Benefits

• Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).
• For more information on our benefits, please visit this link.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior