This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
- Maintain compliance to ISO 9001 for all aspects of the QMS including, but not limited to, Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Complaint Handling, Change Controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement.
- Partner with cross-functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives.
- Author and revise procedures and specifications in collaboration with subject matter experts to ensure clarity, effectiveness, and regulatory compliance.
- Ensure effective training and adoption of quality systems and procedures across the organization.
- Foster a strong cross-functional quality mindset and influence quality ownership at all levels of the organization.
- Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution.
- Apply quality knowledge strategically and operationally across projects within a matrix environment, demonstrating strong negotiation, influence, and facilitation skills.
- Demonstrate strong organizational skills with the ability to effectively multitask, prioritize, and drive results in a dynamic environment.
- Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables.
- Exercise sound judgment, initiative, and problem-solving skills to proactively identify and address quality-related risks.
- Serve as the Management Representative to the ISO 9001 registrar.
- Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data to drive informed decision-making and continuous improvement.
- Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance.
- Maintain internal and external audit schedules and ensure audit readiness across the organization.
- Maintain a risk-based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements.
- Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships.
- Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance.
- Assist with OOS investigations, OOT investigations, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions.
- Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner.
- Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success.
Qualifications
- Bachelor's degree in Engineering, Biology, or Chemistry required.
- Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.
- Minimum of 5-8 years of experience mentoring, developing, and supervising direct reports.
- Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions.
- Strong attention to detail and commitment to quality and compliance.
- Collaborative team player who effectively partners across departments to achieve common goals and drive business success.
- ASQ CQA and/or CQE certification preferred.
- Experience with LEAN implementation strongly preferred.
- Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability.
- Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high-performing and engaged team.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $180,000 - $230,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
Skills Required
- Bachelor's degree in Engineering, Biology, or Chemistry
- Minimum 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment
- Minimum 5-8 years of experience mentoring, developing, and supervising direct reports
- Excellent verbal and written communication skills
- Ability to influence and build strong working relationships across functions
- Strong attention to detail and commitment to quality and compliance
- Collaborative team-player skills and ability to partner across departments
- ASQ CQA and/or CQE certification
- Experience with LEAN implementation
- Ability to foster and sustain a quality culture through leadership, engagement, and accountability
- Ability to mentor, train, coach, and develop quality professionals
What We Do
FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond. Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies. Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.
