Compliance Operations Manager

3 weeks ago


Spokane, Washington, United States Jubilant HollisterStier CMO Full time

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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