Quality/Regulatory Supervisor
About The Position
The Quality / Regulatory Supervisor ensures that Agilent manufactures quality products aligned with and compliant with national, regional, and global regulations, company policies, and business objectives. This working supervisor oversees quality activities supporting a 24/7 pharmaceutical manufacturing operation and leads Manufacturing Quality Engineers. The role provides quality oversight for Manufacturing, Materials Management, and other support functions, translating regulatory requirements into practical, sustainable processes and quality systems. The supervisor participates in day-to-day quality operations while providing leadership, coaching, performance management, and development for direct reports. The position supports site initiatives, customer interactions, audits, and regulatory inspections as needed. Occasional travel is required. The role may require off-shift supervision, including evenings, weekends, and holidays, according to business needs.
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 to ensure compliance with CGMP regulations, ICH guidelines, CFR requirements, and internal quality standards.
- Lead and oversee 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 CGMP documentation, and oversee personnel responsible for documentation review and quality oversight.
- Support internal, customer, and regulatory audits and inspections; partner with cross-functional teams to maintain audit readiness and resolve observations and compliance actions.
- Serve as a 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 the 24/7 operation and supervise off-shift activities, including evenings, weekends, and holidays, as business needs require.
Benefits
- Eligibility for bonus, stock, and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
