Senior Manager, Quality Management

About Servier 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. Job DescriptionCandidate ProfileRole SummaryThe 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.Primary ResponsibilitiesQuality Management ResponsibilitiesCollaborate cross functionally to ensure compliance with quality documents, including standard operating procedures (SOP) and department working practices for the US, as identified with Medical LeadershipReview and approve local deviations, investigations, CAPAs, and change records, including providing quality management guidanceOversee Servier's audit program, including audit preparation, coordination, execution, participation in the review of audit reports, and follow up to any findingsMonitor new and updated Global SOPs for applicability to US quality documentsManage the US training matrix for quality documentsMaintain 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 regulationsEducation and Required SkillsBachelor's degree required, preferably in a scientific, healthcare, or business-related field5+ years of professional experience in developing and maintaining quality systems and creation of standard operating proceduresDemonstrated understanding of GxP and ability to practically apply them internallyIndependent decision making with a high degree of initiativeDetail-oriented with strong organizational and time management skillsKnowledgeable in pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentationExcellent communication and interpersonal skills, with a team-oriented mindset and ability to manage multiple tasksTravel and LocationUp to 10% TravelBoston based preferred, but remote considered for the right candidateServier's CommitmentServier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Salary RangeThe salary range for this role is $141,000 - $161,000. An employee's pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. 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.