Director of Quality & Regulatory
About The Position
The Director of Quality & Regulatory will own and manage the oversight of PL’s quality management system (QMS) across all operations, ensuring it drives consistency, efficiency, and excellence in execution. This role provides both strategic and hands-on leadership, embedding quality principles into daily operations and decision-making. The Manager will champion continuous quality improvement (CQI) initiatives to enhance process reliability, product handling accuracy, and customer satisfaction. Serving as a key partner to fulfillment, operations, and technology teams, this leader ensures that quality is not just maintained but continuously optimized — fostering a culture of performance, accountability, and operational excellence.
Requirements
- Bachelor’s degree in pharmacy, life sciences, engineering, quality management, or related field.
- Minimum of 5 years of experience leading quality operations, process improvement, or QMS management.
- Demonstrated leadership or supervisory experience in a regulated environment.
- Strong knowledge of GDP, GMP, ISO 9001, and FDA regulatory requirements.
- Proven success in implementing and maintaining QMS and managing audits, CAPA, and continuous improvement programs.
- Excellent analytical, communication, and stakeholder management skills.
- Ability to manage multiple priorities and teams
Nice To Haves
- Advanced degree (MS, MBA, PharmD) or professional certification (e.g., ASQ CQE, CQA, ISO Lead Auditor).
- Experience within pharmaceutical logistics, distribution, or manufacturing environments.
- Experience with controlled substances or temperature-sensitive product handling.
- Prior experience supporting ISO certification or regulatory inspection readiness.
Responsibilities
- Foster a culture of accountability, compliance, and continuous improvement within the organization.
- Develop, implement, and maintain the Quality Management System (QMS) in alignment with GDP/GMP, FDA 21 CFR Part 210–211, ISO 9001, and other applicable standards.
- Oversee quality processes including deviation management, change control, CAPA, document control, and supplier quality oversight.
- Lead quality operations reviews, ensuring key metrics are visible, understood, and actioned across sites.
- Manage internal and external audits, including vendor qualification and regulatory inspections.
- Serve as the subject matter expert for GDP, GSP, ISO certification, and quality compliance across pharma logistics operations.
- Design and implement CQI initiatives that enhance storage and transport quality, data integrity, and operational performance.
- Conduct root cause analysis, risk assessments, and trend evaluations to drive corrective and preventive actions.
- Partner with fulfillment, operations, and compliance teams to integrate quality principles into business workflows and logistics practices.
- Track, analyze, and report key quality metrics and performance indicators to leadership.
- Drive digital enablement of quality operations, leveraging data analytics, dashboards, and automation tools to improve visibility and responsiveness.
- Translate quality data and trends into executive insights, influencing decision-making and investment priorities.
- Serve as a champion for operational excellence, leading cross-functional projects that elevate performance, efficiency, and customer experience.
Benefits
- Medical, Dental, and Vision insurance (Blue Cross Blue Shield)
- Group life, AD&D, and long-term disability insurance
- 14 days of paid time off
- Paid major holidays (New Year’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Friday after Thanksgiving, Christmas Day)
- 3% Company contribution on the 1st of the month following 60 days of service
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What This Job Offers
Job Type
Full-time
Career Level
Director
