Head of Global Quality Systems

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:

A leadership role responsible for designing, implementing, maintaining, and improving the Quality Management System (QMS) to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable International Council for Harmonization (ICH) and International Organization for Standardization (ISO) guidelines/standards, other global regulatory requirements as outlined in the BioReliance Testing Services Global Quality Manual, and Merck and Life Science standards and procedure.  Responsible for the analysis, development, and operation of quality and risk management systems.  Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities. Directs the resolution of highly complex or unusual operational problems applying advanced analytical thought. 

• Lead the governance of core quality systems to ensure they are compliant with cGxP regulations, applicable ICH and ISO guidelines, and Merck and LS standards and procedures
• Drive continuous improvement of quality systems and harmonize procedures across global sites 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
• Ensure the review and approval of quality system records including deviations, investigations of Out of Specification (OOS) and anomalous results, CAPA, etc.
• Ensure the robust conduct of investigations to identify root causes and drive continuous improvement across the organization
• Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
• Participate in site readiness activities and provide Quality Systems 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
• Provides leadership and direction through supervisors/managers

Who You Are

Minimum Qualifications:

• Bachelor’s degree in a scientific discipline; advanced degree preferred
• Certification in Lean Six Sigma and a Quality related area is beneficial
• 10+ years working in a cGMP/GLP environment FDA/EMA or equivalent regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution
• 8+ years of leadership experience in Quality Assurance in Bio/Pharmaceutical or Life Sciences industry
• Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change. Previous experience in a client facing Quality role is preferred
• Working knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines
• Expertise in managing and leading the transformation of quality systems such as investigations of nonconformances including deviations and out of specification investigations, corrective actions and preventive actions (CAPA), effectiveness checks, management control, internal audits, and change controls
• Experience with regulated products or services across different geographies preferred
• Mastery in hosting regulatory inspections and managing responses

Preferred Qualifications:

• Fluent in both written and spoken English
• Excellent leadership & management skills
• Excellent communication, interpersonal & conflict resolution skills
• Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
• Leadership experience in building and/or enhancing quality systems such as investigations, change controls, etc.
• Direct experience in communicating with regulatory authorities preferred
• Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills
• Experience of managing a global operation preferred

Pay Range for this position: $154,700-$290,300

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!