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We are an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs. Overview

We are an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.

We are seeking a Quality Director, Global QMS to join our growing Quality team.

You will be part of the Global Quality Leadership team leading the development and monitoring of the Global Global QMS, including the business eQMS system. This leader must be experienced in the development of Quality Management Systems and have a passion for continuous improvement and coaching teams.

Responsibilities

Act as Global QMS system owner. Lead Global QMS process development, SOP periodic reviews, & continuous improvement. Oversee the development & maintenance of Global QMS training curriculum in consultation with the Global QMS Training Snr Manager, Global Doc Control Snr Manager, QA Site leaders and Quality associates responsible for training administration at site level. In association with Snr QA Directors & VP Global Quality, act as Senior Quality reviewer for procedures supporting the Global QMS ensuring the accuracy, completeness, clarity and compliance of content. Act as QMS Coach to site Quality leaders. Collaborate with the Global Training Snr manager on the development and maintenance of the onboarding & annual Global QMS Training module. Report on Global QMS performance metrics to senior management and stakeholders. Support in external audits in relation to Global QMS questions. Promote quality education and compliance culture expectations within the organization via site Media resources and Repligen Quality Portal. Support priority tasks or projects applicable to Quality as assigned by senior management.

Qualifications

Bachelor's Degree in a relevant field such as life sciences, pharmaceuticals or quality management Minimum of 12 years of experience in quality management in the pharmaceutical/life science industry. Minimum 5 years people leadership experience In-depth knowledge of ISO 9001 requirements Experience of implementing QMS systems and Training programs Strong leadership and communication skills, with the ability to effectively lead a team and collaborate with cross-functional teams. Experienced in coaching others and delivering training Experienced QMS Auditor Proficiency in Microsoft suite, SAP Awareness of lean manufacturing principles

What Repligen Offers

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionQuality Assurance Referrals increase your chances of interviewing at Repligen Corporation by 2x Sign in to set job alerts for “Director Global Quality” roles. Somerville, MA $177,000.00-$266,000.00 4 days ago Sr. Director Global Quality Assurance (GLP/GCP) Westwood, MA $80,000.00-$85,000.00 1 month ago Director/Sr. Director, Quality Systems and GxP Compliance Waltham, MA $137,500.00-$261,000.00 6 days ago Deputy Director for Design Quality Assurance Marlborough, MA $157,600.00-$299,500.00 6 days ago Director/Associate Director, Quality Systems Beverly, MA $190,000.00-$240,000.00 1 day ago Walpole, MA $184,500.00-$276,700.00 6 days ago Director, Commercial Operational GMP Quality (Hybrid) Boston, MA $176,000.00-$264,000.00 2 weeks ago Director of Quality and Program Integrity Chelmsford, MA $80,000.00-$90,000.00 1 month ago Senior Director, GCP/GVP Quality Assurance Boston, MA $260,000.00-$275,000.00 5 days ago Senior Director, GCP/GVP Quality Assurance Cambridge, MA $260,000.00-$275,000.00 5 days ago Executive Director, GCP, GLP and GVP QualityAssociate Director, Quality - GMP/ Med DeviceAssociate Director of Biomarker Operational Quality Woburn, MA $120,000.00-$140,000.00 1 week ago Director, Global Regulatory Affairs – Global Labeling Strategy Cambridge, MA $172,500.00-$249,166.66 2 weeks ago Boston, MA $230,000.00-$245,000.00 2 weeks ago Cambridge, MA $230,000.00-$245,000.00 2 weeks ago Associate Director, GMP Operational Quality, Cell & Gene (Wed - Sat, Second Shift)Executive Director, Quality & Patient Safety RN Marlborough, MA $154,200.00-$274,100.00 1 week ago Acton, MA $169,275.00-$253,912.50 1 week ago Senior Medical Director, Pharmacovigilance Boston, MA $320,000.00-$360,000.00 2 days ago AD, QA Evaluations, Integrations & External Srvs Cambridge, MA $138,600.00-$257,400.00 2 weeks ago Associate Director, Biomarker Operational Quality We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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