Senior Quality and Regulatory Manager

Senior Quality and Regulatory Manager Colorcon® is a world leader in the development, supply and technical support of formulated film coating systems, modified release technologies, specialty excipients and functional packaging for the pharmaceutical, nutritional, and animal health industries. Our best-in-class products and technologies are complemented by our extensive formulation experience, application data and value-added services to support all phases of solid oral dose design, development, and manufacture. Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance and reliable supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania. Colorcon has 26 technical service laboratories globally and more than 2100 employees exclusively dedicated to its customer base. We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals. Platinum Rule: We treat others the way they want to be treated Empowerment: We trust our colleagues with responsibility and decision-making Keep Getting Better: We create an environment for constant improvement, to be the best we can Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals Customer Focus: We put our customers’ needs at the heart of everything we do Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to: All employees are eligible to participate in our company-wide bonus program Employees have the choice between three medical plans 100% company-paid Dental Insurance for all employees and their qualifying dependents Optional Vision Coverage Fitness and Wellness Programs Employee Assistance Programs (EAP) Corporate Social Responsibility Groups (CSR) Parental Leave Tuition Reimbursement; up to $8,000 per calendar year 401(k) Company Matching Paid Time Off Paid Holidays 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. 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, ensuring compliance with applicable manufacturing, quality compliance, and regulatory standards while driving continuous improvement initiatives. This role is critical in ensuring product integrity, regulatory compliance, and operational excellence across both manufacturing sites while aligning quality and regulatory objectives with business goals. 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. Responsibilities & Duties 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. 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 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.) Minimum Qualifications 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. Ability to present technical information clearly to non-technical audiences. High level of integrity and commitment to ethical practices in quality and compliance. Demonstrated agility in managing change and driving continuous improvement initiatives. Proven track record of strong time management, organizational, and decision-making skills required. Working Location Position reports to the West Point campus and is primarily an on-site position. Working remotely from a home office will be facilitated when applicable and is at the manager’s discretion. Travel: ≤10% Domestic and International travel required Regular travel between West Point and No-Tox facilities required. Location: 420 Moyer Blvd North Wales, Pennsylvania, 19486 United States Colorcon participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the Form I-9. E-Verify Works for Everyone. For more information on E-Verify, or if you believe that your employer has violated its E-Verify responsibilities, please contact DHS. #J-18808-Ljbffr Colorcon, Inc.