Quality/Regulatory Supervisor

The Quality / Regulatory Supervisor ensures that quality products are manufactured by Agilent and are in alignment and compliance with national, regional, and global regulations, company policies, and business objectives.

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.

Qualifications

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.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 26, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_[email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory