Quality Director - Global QMS
- 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.
- 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
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