We are seeking an experienced Director of Quality candidate to lead Repligen’s Waltham, MA facility which has proven experience in the biotechnology industry. This leader will be responsible for managing the site quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, root cause analysis, customer complaint management, hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site.
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.
This role will be based in Waltham, MA and will report to the Sr. Director, Quality - Quality Network Leader, Chromatography & Proteins.
The Director, Quality will be responsible for:
Maintaining site compliance to ISO 9001 for all aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls, and other product life cycle management activities.
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.
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