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Director of Quality

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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.

Average salary estimate

$135000 / YEARLY (est.)

min

max

$120000K

$150000K

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What You Should Know About Director of Quality, Repligen

If you're looking for a rewarding challenge, the role of Director of Quality at Repligen in Marlborough might just be your next big opportunity. As an experienced professional in the biotechnology industry, you'll lead our quality engineering team, focusing on complaint handling and overseeing our quality assurance team’s daily activities. This includes ensuring compliance with ISO 9001 standards and engaging in activities related to product manufacture, testing, and release. Your expertise will be crucial for managing deviation supports and root cause analysis. Your role will also involve partnering with cross-functional teams to continuously improve procedures and quality systems, ensuring that quality practices resonate throughout the organization. We believe in a collaborative work culture, and your ability to communicate sound quality advice across departments will be fundamental in achieving our quality goals. Being self-motivated with excellent problem-solving skills will help you thrive in our fast-paced environment. Plus, your experience with LEAN implementation and mentoring skills will be a tremendous asset. If you’re excited about fostering a quality culture and are ready to take initiative, we’d love to welcome you to our team at Repligen in Marlborough!

Frequently Asked Questions (FAQs) for Director of Quality Role at Repligen

What are the responsibilities of the Director of Quality at Repligen?

The Director of Quality at Repligen is responsible for overseeing quality engineering and assurance teams, ensuring compliance with ISO 9001 standards, and managing all aspects of product manufacture, testing, and release. This role involves leading complaint handling processes, facilitating operational excellence initiatives in Quality Assurance, and partnering with cross-functional stakeholders to improve quality systems.