Compliance Operations Manager
3 weeks ago
Job Overview:
The Compliance Operations Manager at Jubilant HollisterStier LLC is responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability.
Key Responsibilities:
- Oversee the validation of manufacturing processes, equipment, and systems to ensure they meet regulatory and quality standards.
- Ensure that all qualification, maintenance, metrology, and other records comply with regulatory requirements, including FDA, GMP, and other relevant standards.
- Prepare, review, and maintain detailed documentation of validation and compliance activities, including CAPAs, change controls, protocols, deviations, and reports.
- Support internal and external audits and inspections to ensure compliance with regulatory standards.
- Design and implement training programs for staff on validation and compliance procedures.
- Identify areas for improvement in validation and compliance processes and implement corrective actions.
- Manage validation and compliance projects, including scheduling, resource allocation, and milestone tracking.
Requirements:
- Bachelor's degree in a relevant field.
- 10+ years of pharmaceutical experience.
- Working knowledge of US and EU GMPs.
- Ability to work autonomously and make decisions with minimal supervision.
- Supervisory experience, including staff management and development.
Preferred Qualifications:
- FDA-regulated industry experience.
- 3-5 years of managerial experience.
- Experience with Trackwise Quality Management System.
Benefits:
- Competitive salary range: $101,500 - $178,000.
- Medical, dental, vision, flexible spending, and health savings accounts.
- Life, AD&D, short and long-term disability insurance.
- 401(k) plan with company match.
- Generous paid time off plan.
- Employee assistance program.
Optional Benefits:
- Voluntary life and AD&D insurance.
- Supplemental medical coverage.
- Pet insurance.
- ID theft protection.
- Perk spot discount program.
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