Head of Quality Systems and Compliance

 

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.  

 

Your Role:

This individual will be responsible for implementing and managing the site Quality Systems and Compliance programs. They will be identifying and assessing regulatory and quality risks during site GMP operations ensuring adherence to global regulations and MilliporeSigma’s policies and procedures. This individual will be responsible for leading the continuous inspection readiness efforts and the site's self-inspection program.

 

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

 

Major Position Activities & Responsibilities:

• Develop and execute a strategic vision for the Quality Management System, aligning it with the company's long-term objectives.
• Manage and lead the Quality Systems and Compliance group including quality system management, auditing, and computer system quality assurance.
• Lead the maintenance and continuous improvement of the Quality Management System, including deviation, change control, CAPA, and complaint system with the goal of maximizing efficiency, effectiveness and compliance with all applicable GMP regulations.
• Direct the compliance programs for all cGMP areas and promote a strong Quality culture within the organization.  Identify compliance risks and be a part of the solution through ownership and collaboration.
• Implement and oversee the Computer System Quality Assurance & Data Integrity programs for electronic based systems ensuring compliance with 21 CFR Part 11 regulatory standards.  Ensure site is compliant with global data integrity program expectations.
• Prepare and host quarterly Quality Management Reviews to assess the effectiveness of the Quality Systems; identify unfavorable trends and collaborate with site stakeholders and functions to ensure their timely mitigation.
• Manage Product Quality Review process; continually improve PQR process and work with customers to ensure PQR is driving continuous improvement.
• Manage Quality Agreements between the site and customers; ensure site compliance with agreed upon requirements.
• Responsible for site preparation of regulatory and customer inspections including personnel preparation and training
• Collaborative host of regulatory and customer inspections and audits
• Preparation and approval of follow up activities including responses, commitments, CAPAs, and other strategy plans
• Manage and oversee the self inspection and internal audit programs
• Oversee Complaint and Field Corrective Action system and ensuring compliance with global and regulatory requirements
• Evaluate, contribute, and approve change controls, risk assessments, complaint investigations, CAPAs, and other investigations as they relate to compliance and technical challenges and implementation plans
• Collaborate with functional area leads during planning and process/continuous improvement plans, projects, and gap assessments as they relate to proprietary instruments and manufacturing operations
• Oversee and monitor Quality metrics ensuring data is understandable and translatable to the appropriate audience(s), ensuring site progresses on global heatmap
• Mentor, coach, and manage staff performance and development

 

Who You Are:

 

Minimum Qualifications:

• Bachelor’s degree in a scientific or engineering discipline