Overview
The Senior Manager of Supplier Quality is responsible for leading and managing the supplier quality function within the Supply Chain organization. This role has a significant strategic importance as our supplier base is unique, fragmented, and less mature than Repligen on average from a manufacturing quality perspective. This introduces risk to our customers and our business, meaning the leader in this role has a platform to impact our company's priorities and overall success. At the core, the successful candidate in this role ensures that all suppliers meet or exceed the company's quality standards and regulatory requirements, with a critical emphasis on proactive and risk-balanced prioritization. The Senior Manager of Supplier Quality will develop and implement supplier quality strategies, oversee supplier audits, and work closely with cross-functional teams to drive continuous improvement in supplier performance. In addition, this role is responsible for maintaining a risk-based auditing program supporting supplier qualification initiatives, continuous improvement, and regulatory compliance across all Repligen sites. This position will lead of team of Supplier Quality auditors and ensures and promotes compliance through the management of external auditing of suppliers, vendors, service providers and manufacturers for Repligen Corporation based on ISO 9001 Standard.
Responsibilities
The Senior Manager of Supplier Quality is responsible for leading and managing the supplier quality function within the Supply Chain organization. This role has a significant strategic importance as our supplier base is unique, fragmented, and less mature than Repligen on average from a manufacturing quality perspective. This introduces risk to our customers and our business, meaning the leader in this role has a platform to impact our company's priorities and overall success. At the core, the successful candidate in this role ensures that all suppliers meet or exceed the company's quality standards and regulatory requirements, with a critical emphasis on proactive and risk-balanced prioritization. The Senior Manager of Supplier Quality will develop and implement supplier quality strategies, oversee supplier audits, and work closely with cross-functional teams to drive continuous improvement in supplier performance. In addition, this role is responsible for maintaining a risk-based auditing program supporting supplier qualification initiatives, continuous improvement, and regulatory compliance across all Repligen sites. This position will lead of team of Supplier Quality auditors and ensures and promotes compliance through the management of external auditing of suppliers, vendors, service providers and manufacturers for Repligen Corporation based on ISO 9001 Standard.
Position major responsibilities:
Supplier Quality Strategy and Management:
· Develop and Implement Policies: Design and enforce comprehensive supplier quality policies and procedures that align with organizational objectives and regulatory requirements.
· Leadership: Lead the supplier quality team, providing guidance, support, and professional development opportunities to ensure effective execution of quality initiatives.
· Quality Management Processes: Establish and maintain robust quality management processes for supplier evaluation, selection, and performance monitoring. Ensure all processes are documented and optimized for efficiency.
Supplier Audits and Assessments:
· Develop a detailed audit schedule based on risk assessments, historical performance data, and regulatory requirements. Prioritize high-risk suppliers and those with significant impact on product quality or regulatory compliance.
· Coordinate with cross-functional teams to align audit objectives and ensure comprehensive coverage.
· Conduct thorough on-site and remote audits of supplier facilities, focusing on key areas such as quality control processes, regulatory compliance, manufacturing practices, and supply chain management.
· Utilize various audit techniques, including process audits, system audits, and product audits, to assess supplier adherence to quality standards.
· Engage with supplier personnel at all levels to gather insights and verify compliance with quality requirements.
· Analyze audit findings to evaluate supplier performance against defined quality standards and expectations.
· Utilize feedback and audit outcomes to continuously refine and optimize the auditing process, ensuring it remains robust and effective against evolving industry standards and practices.
· Generate detailed audit reports highlighting non-conformances, potential risks, and areas for improvement.
· Develop supplier scorecards to track performance metrics and trends over time.
· Conduct detailed supplier evaluations, negotiate Quality Agreements, and manage the Approved Supplier List:
· Perform thorough assessments of potential and current suppliers’ capabilities, quality systems, and compliance with industry-specific standards and regulations.
· Ensure that audit findings are documented in a standardized format for global consistency and are followed up with appropriate corrective actions.
· Along with the sourcing team support the negotiation and implementation of Quality Agreements that clearly define quality expectations, roles, responsibilities, and metrics for performance evaluation.
· Regularly review and update the Approved Supplier List to ensure it includes only those suppliers who meet the stringent quality and compliance criteria.
Corrective Actions:
· Work with suppliers to conduct thorough root cause analysis for identified non-conformances.
· Collaborate with suppliers to develop comprehensive corrective action plans addressing root causes. Ensure action plans include specific steps, responsible parties, timelines, and measurable outcomes.
· Monitor the implementation of corrective actions, providing guidance and support as needed. Conduct follow-up audits to verify the effectiveness of corrective actions and ensure sustained compliance.
· Identify opportunities for preventive actions to mitigate future risks. Encourage suppliers to adopt proactive measures and continuous improvement practices to enhance overall quality performance.
· Issue SCARS when required due to complaints or Non-conformances.
· Interact with Site Material Review Boards to understand supplier issues and mitigation activities to prevent Non-conformances.
· Drive pre-Audit communication with various functional groups (R&D, quality, engineering) to ensure scheduled audits are containing specific information on specific concerns or issues.
· Issue SCARS when required due to complaints or Non-conformances.
Generate and review annual supplier scorecards to drive performance improvements.
· Design comprehensive supplier scorecards that incorporate quality metrics, delivery performance, and responsiveness to identify improvement areas.
· Perform thorough assessments of potential and current suppliers’ capabilities, quality systems, and compliance with industry-specific standards and regulations. Maintain up-to-date supplier files including documents to support the addition of suppliers (risk assessments, ISO certificates, questionnaires, audit reports
· Analyze scorecard data to prioritize suppliers for quality improvement initiatives or corrective actions for those suppliers lower than 90%.
· Schedule and conduct review meetings with suppliers to discuss scorecard results, expectations, and future targets.
· Foster transparency by sharing scorecard outcomes with internal stakeholders and integrating feedback into supply chain strategies.
Collaboration and Cross-functional Coordination:
· Collaborate with sourcing, engineering, production, and regulatory teams to ensure seamless integration of supplier quality requirements. Facilitate regular cross-functional meetings to discuss supplier quality issues and improvement plans.
· Lead the development and implementation of standardized quality procedures across all sites, ensuring consistent practices in supplier evaluation and monitoring.
· Address and resolve quality issues promptly. Coordinate with internal and external stakeholders to minimize impact on production. Ensure effective communication and documentation of resolution processes.
· Organize regular virtual and in-person meetings with quality managers from different sites to share best practices and challenges.
· Promote a company-wide quality culture by initiating joint training programs and workshops on quality standards and tools.
· Harmonization of Global Approved Supplier List supporting all Repligen sites
· Conduct Supplier Change notifications –review meetings with Product Management, Engineering and R&D. Issue product impact assessments and risk assessments due to the changes. Identify the required notifications in support of these changes for our customers.
Continuous Improvement:
· Regularly analyze supplier performance data to identify trends and areas for improvement. Implement proactive measures to enhance supplier quality.
· Measure monthly Global Supplier Quality Metrics with trending and report to Sr. Leadership on a monthly basis.
· Lead cross-functional teams to generate data for annual scorecards (delivery, service and quality data) in a timely manner.
· Drive the adoption of industry best practices in supplier quality management. Leverage methodologies such as Six Sigma, Lean, and Total Quality Management (TQM) to optimize processes.
· Identify key suppliers with potential for development and organize targeted meetings with functional groups to enhance their performance.
· Collaborate with suppliers to enhance their manufacturing processes and quality control systems through technical support and shared expertise.
· Monitor the progress of supplier development programs through regular assessments and adjust strategies as necessary to optimize outcomes.
Regulatory Compliance:
· Ensure all supplier quality activities comply with relevant regulatory requirements and industry standards, including ISO 9001, FDA GMP, and other applicable regulations.
· Stay informed about changes in regulations and standards. Update policies and procedures as necessary to maintain compliance.
· Maintain comprehensive records of supplier audits, assessments, and quality performance. Ensure all documentation is accurate and up to date for regulatory reviews.
Qualifications
Traits we believe make a strong candidate.
· Educational Background: bachelor’s degree in engineering, Quality Management, Supply Chain Management, or a related field.
· Master’s degree preferred for advanced expertise and leadership skills.
· Experience: Minimum of 10 years of experience in supplier quality management, with at least 5 years in a leadership role.
· Demonstrated ability to manage teams and complex quality initiatives.
· Quality Systems Knowledge: Strong understanding of quality management systems, standards, and methodologies (e.g., ISO 9001, Six Sigma, Lean). Practical experience in implementing these frameworks.
· Audit Experience: Proven track record in conducting detailed supplier audits and assessments. Ability to identify and mitigate risks effectively.
· Problem-Solving Skills: Exceptional analytical and problem-solving abilities. Ability to identify root causes and develop effective solutions.A
· Communication Skills: Excellent communication and interpersonal skills. Ability to build strong relationships with suppliers and internal teams.
· Team Leadership: Demonstrated ability to lead and manage a team, providing clear direction, support, and development opportunities.
· Certifications: Certification in quality management (e.g., ASQ Certified Quality Engineer, Certified Quality Auditor) is a plus. Certified ISO 9001 Lead Auditor Required.