Quality/Regulatory Supervisor

Agilent Technologies • Frederick, MD

1d

About The Position

The Quality/Regulatory Supervisor ensures that Agilent products are manufactured to meet customer expectations and comply with applicable national, regional, and global regulations, company policies, and business objectives. This working supervisor provides quality oversight for a 24/7 pharmaceutical manufacturing operation and leads Manufacturing Quality Engineers. The role supports Manufacturing, Materials Management, and other site functions, translating regulatory requirements into practical processes and sustainable quality systems.

The supervisor oversees batch record review and disposition, CGMP documentation review, and documentation generation, approval, and retention to support timely product release and compliant operations. The role also supports audits and inspections, maintains audit readiness, and helps resolve observations and compliance actions. It collaborates across functions to address quality issues, investigations, deviations, and CAPAs, and leads continuous improvement while fostering a customer-focused quality culture. The supervisor participates in day-to-day quality operations and provides leadership, coaching, performance management, and development for direct reports. The position supports a 24/7 operation and may involve supervising off-shift activities, including evenings, weekends, and holidays.

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline, or an equivalent combination of education and experience.
• At least 2 years of GMP experience within the pharmaceutical industry.
• At least 3 years of quality experience in a regulated pharmaceutical environment.
• At least 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.

Nice To Haves

• Experience supervising Manufacturing Quality Engineers or quality personnel in a pharmaceutical manufacturing environment.
• SAP, LIMS, and 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.

Responsibilities

• Develop and implement programs, processes, and quality systems to ensure products are safe, compliant, and meet or exceed customer expectations.
• Oversee quality activities supporting a 24/7 pharmaceutical manufacturing operation and lead a team of Manufacturing Quality Engineers.
• Provide quality oversight for Manufacturing, Materials Management, and other support functions, ensuring compliance with CGMP regulations, ICH guidelines, CFR requirements, and internal quality standards.
• Lead batch record review, disposition, and CGMP documentation review activities to support timely product release and compliance.
• Promote a customer-focused quality culture and drive continuous improvement initiatives across the organization.
• Translate regulatory requirements into practical, sustainable processes and quality systems.
• Manage the generation, review, approval, and retention of documentation used in CGMP operations, and oversee personnel responsible for documentation review and quality oversight.
• Support internal, customer, and regulatory audits and inspections; partner with cross-functional teams on audit readiness and timely resolution of observations and compliance actions.
• Serve as a key quality resource for Manufacturing, Materials Management, and other site functions.
• Collaborate with cross-functional teams to resolve quality issues, support investigations, and implement corrective and preventive actions (CAPAs).
• Participate in day-to-day quality operations while providing leadership, coaching, performance management, and development for direct reports.
• Represent Quality during site initiatives, customer interactions, audits, and regulatory inspections as needed.
• Support a 24/7 operation and supervise off-shift activities, including evenings, weekends, and holidays, as business needs require.

Benefits

• Eligibility for bonus, stock, and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager