- Supplier Qualification: Conduct technical evaluations and qualification activities for new and existing suppliers, including assessment of manufacturing processes, capabilities, quality systems, and compliance with Repligen requirements.
- Supplier Audits: Plan and conduct supplier audits, document findings, assess risk, and follow through on corrective actions and improvement opportunities.
- Supplier Quality Issues: Lead supplier-related nonconformance investigations and Supplier Corrective Action Requests (SCARs), including root cause evaluation, corrective action follow-up, and effectiveness verification.
- Supplier Change Management: Evaluate Supplier Change Notifications (SCNs), assess quality and regulatory impact, and coordinate cross-functional reviews and required actions.
- Supplier Performance: Monitor supplier quality performance and trends through scorecards, NCMRs, SCARs, audit results, and other key performance indicators. Partner with suppliers to address performance gaps.
- Supplier Risk and Development: Perform supplier risk assessments and support development plans for key and critical suppliers to reduce quality and supply risk and improve supplier capability.
- Cross-Functional Partnership: Collaborate with Quality, Sourcing, Engineering, Operations, and Regulatory teams on supplier qualification, product and process validation, supplier changes, and quality improvement activities.
Qualifications
- Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- 7+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
- Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
- Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.
- Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
- Strong problem-solving, analytical, communication, and cross-functional collaboration skills.
- Ability to travel to supplier locations as required.
Preferred Qualifications
- Experience within life sciences, biopharmaceutical manufacturing, medical devices, or another regulated industry.
- ASQ certification, Lead Auditor certification, or similar quality certification.
- Experience with statistical methods, process capability, validation, or continuous improvement tools.
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 salary range for this role, based in the United States of America is $130,000-$145,000. 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, Quality, Life Sciences, or a related technical discipline, or equivalent relevant experience.
- 7+ years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
- Experience with supplier qualification, supplier audits, nonconformance investigations, CAPA/SCAR, and root cause analysis.
- Working knowledge of quality management systems and applicable regulatory requirements, including GMP and FDA requirements.
- Ability to evaluate manufacturing processes, technical documentation, and supplier quality systems.
- Strong problem-solving, analytical, communication, and cross-functional collaboration skills.
- Ability to travel to supplier locations as required.
- Experience within life sciences, biopharmaceutical manufacturing, medical devices, or another regulated industry.
- ASQ certification, Lead Auditor certification, or similar quality certification.
- Experience with statistical methods, process capability, validation, or continuous improvement tools.
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.
