REGULATORY COMPLIANCE SUPPLIER QUILITY MGR

Job Responsibilities

Formulated Solutions is seeking a Manager, Corporate Regulatory, Compliance & Supplier Quality. This position manages enterprise-wide regulatory compliance and supplier quality programs, ensuring that applicable regulatory, cGMP, customer, contractual, and company requirements are consistently implemented and maintained through effective quality-system and supplier controls across company sites.

Reporting to the VP of Quality, the Manager provides day-to-day leadership to employees assigned to Regulatory, Compliance, and Supplier Quality activities. This role partners with Quality Assurance, Regulatory Affairs, Quality Control, Operations, Supply Chain, Procurement, Innovation and Development, Analytical R&D, Product Development, Commercial, and site leadership to support inspection readiness, supplier qualification and monitoring, compliance assessments, continuous improvement, performance metrics, and timely escalation of significant risks.

Essential Duties and Responsibilities

Corporate Regulatory and Compliance

• Manage the execution and maintenance of enterprise compliance programs across Formulated Solutions locations.
• Implement and maintain compliance standards, procedures, tools, and supporting controls.
• Translate regulatory, cGMP, customer, and contractual requirements into practical quality-system and business expectations.
• Identify compliance risks and lead the development, tracking, and effectiveness evaluation of risk-based remediation actions.
• Partner with site Quality teams to promote consistent interpretation and execution of company compliance requirements.
• Support FDA and other regulatory inspections, customer audits, internal audits, and inspection-readiness activities.
• Participate in investigations, CAPAs, change controls, risk assessments, management reviews, and remediation initiatives.
• Analyze deviations, audit findings, CAPAs, and quality events for systemic or cross-site trends and escalate significant concerns.
• Maintain compliance dashboards and report significant risks, trends, and remediation status to Quality leadership.
• Monitor regulatory and industry developments and coordinate assessments of potential business and quality-system impact.
• Monitor applicable USP/NF and other recognized compendial updates. Partner with Quality Control, Regulatory Affairs, Supplier Quality, and Technical teams to assess, document, and implement required changes to materials, specifications, test methods, inspection records, and quality systems.
• Oversee site registrations and certifications, including renewals and ongoing maintenance, to ensure they remain current and in good standing.
• Coordinate responses to regulatory observations, customer findings, and significant compliance matters.

Supplier Quality

• Manage the enterprise Supplier Quality program and ensure consistent execution across company sites.
• Coordinate risk-based supplier qualification, approval, monitoring, requalification, and disqualification activities.
• Ensure supplier categorization and controls are proportionate to material, service, product, regulatory, and business risk.
• Coordinate and participate in supplier audits, quality assessments, corrective actions, and improvement initiatives.
• Manage significant supplier CAPAs through closure and effectiveness evaluation.
• Maintain supplier performance monitoring, metrics, risk profiles, and periodic business reviews.
• Coordinate the development, review, execution, and maintenance of Quality Agreements and related supplier documentation.
• Partner with Procurement, Supply Chain, Quality, Regulatory Affairs, Operations, and Technical functions during supplier selection, onboarding, qualification, and changes.
• Ensure supplier changes and notifications are routed for appropriate quality, regulatory, technical, customer, and business-impact assessments.
• Monitor and escalate supplier risks affecting product quality, compliance, continuity of supply, or customer requirements.
• Recommend supplier approval, conditional approval, restriction, suspension, or disqualification based on documented risk and performance.

Quality-System Integration

• Partner with Quality Assurance and Regulatory Affairs to incorporate applicable regulatory and compliance requirements into quality systems and operating processes.
• Evaluate compliance implications associated with significant supplier, process, system, organizational, and regulatory changes.
• Support quality policies and systems applicable to OTC drugs, cosmetics, pharmaceutical products, medical devices, and other regulated product categories within the company portfolio.
• Support remediation resulting from inspections, customer audits, internal audits, regulatory assessments, and quality-system reviews.

People Leadership

• Supervise, coach, and develop direct reports assigned to Regulatory, Compliance, and Supplier Quality responsibilities.
• Establish priorities, accountability, performance expectations, and workload assignments based on compliance, supplier, customer, and business risk.
• Support employee development, cross-training, and functional capability within assigned areas.
• Ensure employees understand applicable procedures, responsibilities, and escalation expectations and have the resources needed to perform assigned work.
• Coordinate cross-functional initiatives involving multiple sites or departments.
• Promote timely identification and escalation of quality and compliance risks and collaboration across Quality, Regulatory Affairs, Supply Chain, Procurement, Operations, Commercial, and Technical functions.

Metrics and Performance Management

• Maintain and report metrics for supplier qualification and requalification, supplier audits, CAPA aging and effectiveness, supplier changes, and supplier risk and performance trends.
• Maintain compliance metrics for audit and inspection observations, CAPA aging and recurrence, repeat deviations, remediation status, inspection readiness, and significant risk trends.
• Use metrics and trend analysis to identify adverse patterns, prioritize actions, and communicate actionable information to Quality leadership.

Decision Authority

• Manage assigned Regulatory, Compliance, and Supplier Quality activities in accordance with established procedures and delegated authority.
• Establish and prioritize work assignments and require appropriate follow-up or corrective action when requirements are not met.
• Recommend supplier qualification and monitoring strategies, approval status, restrictions, suspension, or disqualification based on documented risk.
• Escalate significant or systemic compliance and supplier-quality risks to the VP of Quality or designated Quality leadership.
• Recommend additional controls or temporary restrictions when documented risk warrants further action.
• Perform other duties as assigned.

Critical Skills and Abilities

• Strong knowledge of cGMP requirements, regulated quality systems, regulatory compliance, and risk-management principles.
• Strong supplier quality experience, including qualification, auditing, CAPAs, Quality Agreements, change management, and performance monitoring.
• Ability to recognize patterns across events, suppliers, sites, and processes and recommend practical, risk-based solutions.
• Ability to evaluate quality, technical, regulatory, supplier, contractual, and operational information and reach clear, documented conclusions.
• Sound judgment when balancing compliance, product quality, patient or consumer protection, customer commitments, business continuity, and operational needs without compromising requirements.
• Demonstrated people leadership, including setting expectations, assigning work, coaching employees, and addressing performance gaps.
• Ability to influence and collaborate with cross-functional teams across multiple sites.
• Excellent written, verbal, presentation, project-management, analytical, and organizational skills.
• Ability to develop meaningful metrics, analyze trends, identify risk, and communicate recommendations to leadership.
• High professional integrity, discretion, objectivity, and willingness to escalate significant concerns.

Education and Experience

• Bachelor's degree in Regulatory Affairs, Pharmaceutical Sciences, Chemistry, Biology, Engineering, Quality, or a related scientific or technical discipline required.
• Seven to ten years of progressive Regulatory Affairs and Quality Compliance experience within FDA-regulated industries.
• Demonstrated experience supporting regulatory inspections, customer and internal audits, investigations, CAPAs, change controls, and risk assessments.
• Experience interpreting and implementing applicable regulatory and compendial requirements.
• Supplier Quality experience involving qualification, audits, CAPAs, Quality Agreements, supplier changes, and performance monitoring.
• Prior supervisory or team-lead experience with responsibility for direct reports strongly preferred.
• Experience in a CDMO/CMO, pharmaceutical, or other FDA-regulated manufacturing organization strongly preferred.
• Advanced degree and/or professional certification such as RAC, ASQ Certified Quality Auditor, Certified Manager of Quality/Organizational Excellence, or comparable certification preferred.
• Experience with eQMS, supplier-management, document-management, regulatory-information, and data-analytics systems preferred.