Compliance Manager

5 days ago

Spokane, Washington, United States Jubilant HollisterStier CMO Full time

Jubilant HollisterStier CMO is a leading pharmaceutical company that provides innovative solutions to the industry. We are seeking a highly skilled Compliance Manager to join our team.

Job Summary

The Compliance Manager will be responsible for ensuring that all manufacturing equipment, processes, and documentation meet regulatory standards and demonstrate suitability. This includes overseeing the validation of manufacturing processes, equipment, and systems to ensure they meet regulatory and quality standards.

Key Responsibilities

  • Validation Management: Oversee the validation of manufacturing processes, equipment, and systems to ensure they meet regulatory and quality standards.
  • Compliance Oversight: Ensure that all qualification, maintenance, metrology, and other records comply with regulatory requirements, including FDA, GMP, and other relevant standards.
  • Documentation and Reporting: Prepare, review, and maintain detailed documentation of validation and compliance activities, including CAPAs, change controls, protocols, deviations, and reports.
  • Audit and Inspection Support: Support internal and external audits and inspections to ensure compliance with regulatory standards.
  • Training and Development: Design and implement training programs for staff on validation and compliance procedures.
  • Continuous Improvement: Identify areas for improvement in validation and compliance processes and implement corrective actions.
  • Project Management: 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.
  • Office software skills (Word, PowerPoint, Excel, Teams).
  • Working knowledge of US and EU GMPs.
  • Ability to work autonomously with high ownership and supervise salaried and hourly staff.

Preferred Qualifications

  • FDA-regulated industry experience.
  • 3-5 years of managerial experience.
  • Trackwise Quality Management System experience.

Benefits

  • Medical, dental, vision, flexible spending, and health savings accounts.
  • Life, AD&D, short-term, and long-term disability insurance.
  • 401(k) with company match.
  • Generous paid time off plan.
  • Employee assistance program.

Optional Benefits

  • Voluntary life and AD&D insurance for employees and families.
  • Supplemental medical coverage (critical illness, hospital indemnity, and accident coverages).
  • Pet insurance.
  • ID theft protection.
  • Perk spot discount program.

Jubilant HollisterStier CMO is an equal opportunity employer and welcomes applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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