Overview

We are seeking an experienced Director of Quality candidate to lead Repligen’s Marlborough, MA facility which has proven experience in the biotechnology industry. The successful candidate will lead the sites quality engineering team supporting complaint handling.  This leader will also be responsible for managing the sites quality assurance team which includes all day-to-day activities for product manufacture, test and release including deviation support, OOS support, root cause analysis, and Certificate of Quality generation. 

Responsibilities

·         Maintain 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 muti-talk 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 engineering team responsible for complaint handling for the Marlborough 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.

·         Maintain risk-based strategy for overall Quality compliance across the organization and in support of ISO 9001.

·         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.

·         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 13485, or ISO 9001 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.