Director, Quality at Repligen in Waltham, MA

Overview

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.

Responsibilities

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.

Partner with cross-functional stakeholders for continuous improvement activities; create and revise procedures, practices, and specifications; provide training on quality system and procedures.
Maintain strong cross-functional quality focus; build, maintain, and spread knowledge throughout the organization.
Ability to effectively communicate sound quality advise cross-functionally, based on regulations and business needs.
Demonstrated ability to apply knowledge strategically and operationally across projects within a matrix environment; strong negotiation and facilitation skills.
Strong organization skills with the ability to effectively multi-task and prioritize
Ability to adapt to changing business needs and meet timelines within a fast-paced environment.
Self-motivated with sound judgment and problem-solving skills.
Serve as the Management Representative to the ISO 9001 registrar.
Manage the quality team responsible for complaint handling for the Waltham manufacturing site.
Develop, Monitor and Compile Quality metrics as inputs for monthly KPI’s and management review meetings with the Senior Management team.
Facilitate operational excellence initiatives in Quality Assurance.
Maintain internal and external audit schedules; serve as host for site audits
Maintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO 9001 standard.
Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. Review and approve New Product Development Design History Files for the site.
Assists with OOS investigations, OOT investigations and NCMR investigations.
Completes required actions for identified corrective/preventive actions for the Quality department.
Keep up to date with current trends in biopharmaceutical manufacturing.
Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.

Qualifications

Bachelor’s degree in Engineering, Biology or Chemistry degree required.
Minimum of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.
Minimum 5-8 years of experience mentoring and supervising direct reports.
Excellent verbal and written communication skills.
Strong attention to detail.
Enthusiastic, team player, collaborative across all departments to achieve the common goals.
ASQ CQA and/or CQE certificate preferred.
Experience with LEAN implementation strongly preferred.
Demonstrated ability to foster a Quality Culture across the organization.
Demonstrated ability to mentor, train, and guide quality department.

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.