We are seeking a Vice President of Regulatory Affairs and Quality to provide enterprise leadership for regulatory affairs, quality assurance, and quality control in a manufacturing environment. This executive will establish and execute the global regulatory and quality strategy, ensure that products and operations meet applicable requirements, and build scalable systems that support innovation, commercialization, and sustainable growth.
MUST HAVE: Experience in directing the preparation, submission, and maintenance of regulatory dossiers, registrations, notifications, and approvals across applicable jurisdictions and product categories.
This hands-on executive position requires the ability to translate complex regulatory and quality requirements into practical business strategies and to lead effectively across scientific, technical, manufacturing, commercial, and corporate functions. The Vice President will serve as a trusted advisor to the executive team.
Responsibilities
Regulatory Affairs
- Define and lead the global regulatory strategy for the company's product portfolio, innovation pipeline, market expansion, and lifecycle management activities.
- Direct the preparation, submission, and maintenance of regulatory dossiers, registrations, notifications, and approvals across applicable jurisdictions and product categories.
- Advise executive leadership and cross-functional teams on regulatory pathways, emerging requirements, business risk, and the regulatory implications of strategic decisions.
- Establish effective relationships with regulatory authorities, scientific experts, external organizations, and industry associations, and represent the company in relevant regulatory and scientific forums.
- Maintain an enterprise horizon-scanning process for regulatory and scientific developments, assess their impact, and ensure timely risk mitigation and communication to business leaders.
- Provide regulatory leadership throughout product development and commercialization, including claims, labeling, specifications, customer requirements, and market access.
Quality Assurance/Quality Control
- Provide executive leadership, direction, and development for the Quality Assurance and Quality Control functions, including organizational design, talent planning, and succession readiness.
- Own the enterprise Quality Management System and ensure it is scalable, risk-based, and compliant with applicable laws, regulations, industry standards, and customer requirements.
- Establish quality governance, policies, procedures, records, and management-review processes supporting product development, technology transfer, manufacturing, release, distribution, and post-market activities.
- Oversee product quality, laboratory controls, supplier quality, change control, deviations, investigations, corrective and preventive actions, complaints, and document control.
- Direct internal, supplier, customer, and regulatory audit programs; ensure timely remediation of findings; and maintain organizational readiness for inspections.
- Serve as the senior quality authority for product disposition, significant quality events, regulatory inspections, recalls, and other matters requiring independent quality judgment and escalation.
Management and Continuous Improvement
- Present regulatory and quality strategy, performance, material risks, resource needs, and improvement priorities to executive leadership and other key stakeholders.
- Build a culture of quality, compliance, accountability, and continuous improvement across the organization through visible leadership, education, and cross-functional partnership.
- Establish and monitor key performance and risk indicators, management dashboards, and operating reviews to measure program effectiveness and drive fact-based decisions.
- Develop annual operating plans, budgets, staffing models, and external-partner strategies for Regulatory Affairs and Quality, ensuring resources align with business priorities and risk.
- Sponsor cross-functional initiatives that improve compliance, strengthen process capability, reduce risk and cost of poor quality, and enable reliable scale-up and commercialization.
Education and Experience Requirements
- Bachelor?s degree or Master?s degree in regulatory affairs, quality, chemistry, biology, microbiology, engineering, food science, pharmaceutical sciences, or a related scientific or technical discipline required; advanced degree preferred.
- Minimum of 12 years of progressively responsible experience in regulatory affairs, quality assurance, quality control, or related functions within biotechnology, food ingredients, specialty chemicals, pharmaceuticals, or another regulated manufacturing industry.
- At least five years of senior leadership experience with responsibility for regulatory and/or quality teams, enterprise systems, budgets, and cross-functional programs.
- Demonstrated experience developing global regulatory strategies, leading interactions with regulatory authorities, supporting product registrations or market authorizations, and maintaining inspection readiness.
- Strong knowledge of quality management systems, risk management, audits, investigations, corrective and preventive actions, supplier quality, product release, and applicable regulatory and industry standards.
Travel Requirements
- Approximately 20% travel is required for company-site visits, regulatory or customer meetings, audits and inspections, industry conferences, and other business needs. Travel may include domestic and occasional international destinations.