Senior Quality and Regulatory Manager

Senior Quality and Regulatory Manager

Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.

The Senior Quality and Regulatory Manager is accountable for overseeing quality systems and providing strategic oversight of regulatory activities across the West Point and No‑Tox manufacturing locations. The role ensures compliance with applicable manufacturing, quality, and regulatory standards while driving continuous improvement initiatives. The Senior Quality and Regulatory Manager reports directly to the Site Director for West Point and No‑Tox and maintains matrixed responsibilities to Global Quality, with dotted line reporting to the Global Head – Innovation, Quality and Regulatory Affairs.

• Lead site Quality Assurance, Quality Control, and Regulatory departments with independence and authority to ensure compliance with corporate, industry, and regulatory quality standards.
• Maintain and improve compliance with ISO 9001, SQF, IPEC, and EXCiPACT standards.
• Serve as site quality representative in cross‑functional leadership meetings and regulatory and certification audits.
• Provide leadership, direction, and prioritization for the Regulatory Affairs team, ensuring effective resourcing and alignment to business, quality, and customer needs.
• Ensure appropriate regulatory representation and input for NALAN within site, regional, and global initiatives, including participation in cross‑site collaboration and adoption of best practices.
• Identify and mitigate quality risks through proactive analysis of quality systems and processes and implementation of preventative measures.
• Ensure regulatory compliance risks, trends, and significant changes are proactively identified and communicated to site and global leadership.
• Collaborate with operations, engineering, maintenance, safety and supply chain departments to optimize and maintain quality system processes.
• Provide strategic direction to align quality initiatives with business goals.
• Lead validation activities for equipment, processes, and methods to ensure consistent product quality and regulatory compliance.
• Manage supplier qualification and monitoring programs to confirm material quality and compliance.
• Implement, monitor and report on quality metrics, trends, and KPIs to drive continuous improvement.
• Support investigations into internal and external nonconformances, ensuring timely root cause analysis and effective CAPA implementation.
• Serve as the site’s SQF Practitioner.
• Foster collaborative relationships focused on product quality and process quality to ensure continual compliance with internal, regulatory, and statutory requirements.
• Participate in regional/global collaborative projects designed to enhance the synergies of multiple Quality Systems.
• Develop training programs for Quality Assurance and Quality Control staff to ensure competency and compliance with cGMP, cGLP, and other quality systems.
• Effectively communicate all department and company policies as they relate to the daily maintenance of the Quality Management System.
• Manage all daily Site Management Team responsibilities (i.e. meeting representative, project lead, etc.).

• Bachelor’s degree in a science discipline and a minimum of five (5) years of Quality Assurance and/or Quality Control experience.
• Minimum of three (3) years of management experience in Quality and hold a recognized Quality Management Certification (e.g., ASQ Certified Quality Manager, ISO Lead Auditor, etc.).
• Minimum of ten (10) years of industry experience in a laboratory environment.
• Experience in regulatory affairs or providing regulatory leadership within a regulated manufacturing environment preferred.
• cGMP manufacturing experience required.
• ERP System experience required.
• Demonstrated ability to lead cross‑functional teams and manage departmental budgets.
• Experience coaching and developing high‑performing teams…