Quality/Regulatory Supervisor
$105.28k - $164.5kAgilent
Agilent seeks a Quality/Regulatory Supervisor to oversee pharmaceutical manufacturing operations in Frederick, Colorado. The role ensures product compliance with GMP regulations and quality standards while leading a team of Manufacturing Quality Engineers and supporting 24/7 operations.
Responsibilities
- Develop and implement quality programs and systems ensuring product safety and regulatory compliance
- Oversee batch record review, disposition, and CGMP documentation activities for timely product release
- Lead Manufacturing Quality Engineers and provide quality oversight across manufacturing and support functions
- Support investigations, deviations, CAPAs, and audits; partner with cross-functional teams on compliance actions
- Manage CGMP documentation generation, review, and retention; supervise off-shift and 24/7 operations as needed
Requirements
- Bachelor's degree in science, engineering, or related discipline
- Minimum 2 years GMP experience in pharmaceutical industry
- Minimum 3 years quality experience in regulated pharmaceutical environment
- Minimum 2 years leadership or supervisory experience
- Experience reviewing and approving batch records and CGMP documentation
- Knowledge of CGMP regulations, ICH guidelines, and CFR requirements
- Strong communication, organizational, and problem-solving skills
Compensation: $105,280–$164,500 base per year, plus bonus, stock, and benefits eligibility
Vacancy posted 5 days ago
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