Quality/Regulatory Supervisor

Responsibilities

• Develops and implements programs, processes, and quality systems to ensure products are safe, compliant, and meet or exceed customer expectations. Oversees quality activities supporting a 24/7 pharmaceutical manufacturing operation and leads a team of Manufacturing Quality Engineers.
• Provides quality oversight for Manufacturing, Materials Management, and other support functions, ensuring compliance with CGMP regulations, ICH guidelines, CFR requirements, and internal quality standards.
• Leads and oversees batch record review, disposition, and CGMP documentation review activities to ensure timely product release and compliance with regulatory and company requirements.
• Acts as a change agent to foster a customer-focused quality culture while driving continuous improvement initiatives across the organization.
• Provides expertise in translating regulatory requirements into practical, sustainable processes and quality systems.
• Manages the generation, review, approval, and retention of documentation used in CGMP operations and oversees personnel responsible for documentation review and quality oversight activities.
• May support internal, customer, and regulatory audits and inspections. Partners with cross-functional teams to ensure audit readiness and timely resolution of observations and compliance actions.
• Serves as a key quality resource for Manufacturing, Materials Management, and other site functions. Collaborates with cross-functional teams to resolve quality issues, support investigations, and implement corrective and preventive actions (CAPAs).
• Functions as a working supervisor, actively participating in day-to-day quality operations while providing leadership, coaching, performance management, and development for direct reports.
• Represents Quality during site initiatives, customer interactions, audits, and regulatory inspections as needed.
• Supports a 24/7 operation and may be required to supervise off-shift activities, including evenings, weekends, and holidays.

Minimum Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline, or an equivalent combination of education and experience.
• Minimum of 2 years of GMP experience within the pharmaceutical industry.
• Minimum of 3 years of quality experience in a regulated pharmaceutical environment.
• Minimum of 2 years of leadership, supervisory, or people management experience.
• Experience reviewing and approving batch records and CGMP documentation.
• Knowledge of CGMP regulations, ICH guidelines, CFR requirements, and quality systems.
• Experience supporting investigations, deviations, CAPAs, and change controls.
• Strong communication, organizational, and problem-solving skills.
• Ability to support a 24/7 manufacturing operation, including off-shift, weekend, and holiday coverage as business needs require.

Preferred Qualifications

• Experience supervising Manufacturing Quality Engineers or quality personnel in a pharmaceutical manufacturing environment.
• SAP, LIMS, BM/RAM experience.
• Experience with electronic document management systems.
• Experience supporting internal, customer, supplier, and regulatory audits.
• Experience with batch disposition and product release activities.
• Experience supporting regulatory inspections and compliance programs.