Manager/Director of Quality Assurance


Summary

The Head of QA will be a seasoned professional who offers thorough knowledge of all aspects of Quality Management as well as deep and broad knowledge of Quality regulations and practices. Beyond the technical capabilities, we seek a hands-on and impactful leader with a demonstrated track record of implementing quality systems and continuous improvement initiatives in a high growth, fast-paced environment. We are seeking a leader who thrives in an evolving setting. 

Reporting to Executive Management, the Head of Quality Assurance is primarily responsible for the establishment and management of the company’s Quality Systems to ensure that drug development and registration activities are compliant with all applicable regulatory requirements and guidelines.

Essential Duties:

  • Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures.
  • Manage the day-to-day activities of the QA group and the Quality Systems with respect to the writing, review and approval of GMP documentation and business practices.
  • Participate in all plant activities to ensure cGMP compliant manufacturing and PAI readiness.
  • Lead internal and external GMP audits, including the timely preparation of audit reports.
  • Develop and chair the Quality Management Review Board.
  • Perform review of regulatory submission documents in support of submissions to regulatory authorities, as required.
  • Advise senior management on findings and recommendations related to quality.
  • Perform Manufacturing Batch review and disposition.
  • Monitor production operations, including Quality Control, for SOP and cGMP compliance.
  • Maintain current knowledge of new regulatory developments.
  • Other duties as assigned.

Qualifications:

  • BS in chemistry, biology or related field
  • 10 years experience in quality management Excellent organizational skills and attention to detail.
  • Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
  • Familiar with the necessary components of facility qualification and validation activities.
  • Extensive knowledge of cGMP regulations and ICH guidelines.
  • Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners.
  • Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
  • Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team.