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.
