Senior Quality and Regulatory Manager

About the role

The Senior Quality and Regulatory Manager oversees quality systems and provides strategic oversight of regulatory activities across the West Point and No-Tox manufacturing locations. This role ensures compliance with applicable manufacturing, quality compliance, and regulatory standards while driving continuous improvement initiatives.

Responsibilities

• 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.
• Provides 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.
• 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 at enhancing 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.).

Requirements

• Bachelor’s degree in science discipline and a minimum of five (5) years of Quality Assurance and/or Quality Control experience required.
• Minimum of 3 years of management experience in Quality and hold a recognized Quality Management Certification required. E.g. ASQ Certified Quality Manager, ISO Lead Auditor, etc.
• Minimum of 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 in a regulated manufacturing environment.
• Strong interpersonal skills with the ability to build relationships and communicate effectively across all levels of the organization.
• Skilled in conflict resolution and navigating complex stakeholder dynamics.
• Able to present technical information clearly to non-technical audiences.
• Demonstrated agility in managing change and driving continuous improvement initiatives.
• Proven track record of strong time management, organizational, and decision-making skills required.

Qualifications

• Bachelor’s degree in science discipline.
• Minimum of five (5) years of Quality Assurance and/or Quality Control experience.
• Minimum of 3 years of management experience in Quality and hold a recognized Quality Management Certification.
• Minimum of 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 in a regulated manufacturing environment.
• Strong interpersonal skills with the ability to build relationships and communicate effectively across all levels of the organization.
• Skilled in conflict resolution and navigating complex stakeholder dynamics.
• Able to present technical information clearly to non-technical audiences.
• Demonstrated agility in managing change and driving continuous improvement initiatives.
• Proven track record of strong time management, organizational, and decision-making skills.