Head of Supplier Quality Management

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role:

• Lead the governance of the SQM system to ensure compliance with cGxP regulations, applicable ICH and ISO guidelines/standards, and Merck and LS standards and procedures
• Serve as a technical authority in drug regulations and industry standards specifically related to supplier quality to ensure consistency in interpretation of cGxPs throughout the business
• Develop and execute strategic plans to improve supplier quality and costs on a global basis
• Identify strategic initiatives to drive continuous improvement opportunities within the SQM system and harmonize procedures across sites globally to enhance efficiency
• Leverage close collaboration across different geographies (US, EU, UK, APAC) and proactively seek support from key stakeholders to obtain the required input and alignment with Quality strategies
• Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed
• Create, manage, and drive effective plans to improve the culture of quality with defined actions, timelines, and KPI reporting to BioReliance CTS leadership, Quality and site leadership, or other Merck stakeholders as required
• Manage supplier quality resources in the areas of strategic sourcing, new product development, and at key suppliers ensuring the assessment, qualification, and approval process for suppliers are based on risk, QMS capabilities, and technical competence
• Provide oversight for supplier qualification activities including scheduling, planning, and conduct of supplier audits and participate in development and negotiation of Quality Agreements
• Manage supplier nonconformance, investigations, and corrective actions and preventive actions (CAPA) to resolve quality issues
• Evaluate supplier-initiated change notifications and conduct risk assessments for materials and services
• Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
• Participate in site readiness activities and provide SQM support in managing client audits, internal audits, and regulatory inspections
• Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate
• Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones

 

Financial Dimension

• Manage resource and financial planning to ensure alignment with business needs and quality requirements.

 

Management of People

• Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements
• Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation
• Actively manage the performance and development of teams using available tools and procedures, ensuring all team members have appropriate goals and objectives set.

 

Who You Are

Minimum Qualifications:

• Bachelor’s degree in a scientific discipline; advanced degree preferred
• Quality certification in auditing or a Quality related discipline
• 8+ years working in a cGMP/GLP environment/FDA/EMA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution
• 5+ years of leadershi