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Compliance Director

Omaha, NE 68101

Posted: 02/02/2023 Employment Type: Direct Hire Job Number: 21825

Job Description

Full time, Onsite

Are you looking to make a career change to a rapidly growing, stable, innovating manufacturing pharmaceutical company?  This exciting opportunity as a Compliance Director offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, paid PTO, etc.  Does this position match your future career goals? Then this Compliance Director opportunity could be the right fit for you.

  • The Compliance Director will lead, assist all trainings and oversee all Compliance, Regulatory Affairs and Safety personnel.
  • Must ensure the FDA compliance, including inspection preparation, training and readiness in all facilities.
  • Must write, review and approve Regulatory and Quality Assurance documents, as well as review/approve Chemistry and Microbiological documents.
  • Must direct/coordinate outside consultants for cGMP and regulatory requirements.
  • Conduct Audit and work closely with internal and external partners to assure current Good Manufacturing Practices (cGMP) compliance.
  • Must assist in development, maintenance and monitoring of the various departmental tracking systems and prepare reports as required.
  • The Compliance Director must review and approve validation protocols, facility and equipment change, control documents and equipment qualification reports as needed.
  • Must assist QA in overseeing and monitoring the internal and external audit schedules and programs.
  • Must assist QA to plan company-wide cGMP training.

  • The Compliance Director must have a bachelor’s degree in a science or related field.
  • Must have a minimum of 7 years work experience in a manufacturing set up working with FDA Q7 and current Good Manufacturing Practices (cGMP)
  • Must have 5 years of supervisory experience in a manufacturing set up.
  • Must have a thorough knowledge of FDA regulations and practices (21 CFR 11, 21 CFR 111, 21 CFR 117 and/or 21 CFR 210/211) Regulatory Affairs, Quality Assurance, Chemistry or Microbiology Laboratory practices.
  • Must have a strong understanding of quality assurance practices, manufacturing processes, GMP, documentation, and data integrity requirements.
  • Must be flexible in schedule, be available on weekends, if needed
  • The Compliance Director must have strong written and verbal communication skills.
  • Must be proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.
  • Must be willing to commute/ travel as needed.
  • Must be willing to work on-site and be fully vaccinated.

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Direct Hire
  • Paid time off.
  • Bonus

Salary: $100K-$140K annually

Ask for: Amrita Mukherjee

Job Id: 21825

Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.

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