Director of Quality

3 weeks ago

Exton, United States Medix™ Full time

Management & Organization

  • Uphold company's values of Integrity, Excellence, and Respect for People. Ensure employees are well-trained on ethics and compliance policies.
  • Promote a safe and healthy work environment, actively engaging the Quality team in HSE programs and driving improvements toward site goals.
  • Ensure staff qualifications and training, including GMP education, are up-to-date.
  • Develop personnel capabilities in technical expertise, behavioral skills, and management.
  • Communicate quality objectives and priorities clearly to all site staff.
  • Manage resources effectively to meet quality objectives and site priorities, including anticipating future business needs related to headcount and finances.
  • Recruit, coach, and develop quality unit personnel.
  • Ensure quality activities align with procedural requirements and meet planned timelines.
  • Provide both administrative and technical support to the site’s quality unit.


Quality Compliance

  • Maintain the independence of the Site Quality Unit.
  • Develop, maintain, and ensure the effectiveness of the site’s quality management system.
  • Ensure systems are in place for the release or rejection of raw materials, intermediates, packaging materials, components, and consumables.
  • Oversee the evaluation and release of batch records according to regulations and company standards.
  • Ensure necessary controls, testing, and monitoring are conducted in line with marketing authorizations.
  • Approve specifications, sampling instructions, test methods, and batch records.
  • Maintain all required quality agreements.
  • Verify that site processes, equipment, instruments, utilities, and facilities are qualified/validated and maintained.
  • Participate in the approval of Annual Product Reviews.
  • Ensure site audit and inspection readiness, host audits, and ensure timely closure of regulatory commitments.
  • Ensure the adequacy and effectiveness of the site quality systems.
  • Serve on the Site Lead Team and lead the Quality Lead Team.
  • Ensure compliance with GMP regulations, company’s Quality standards, and regulatory requirements by reviewing and approving GMP documentation.
  • Maintain compliance status through gap assessments of corporate and regulatory standards and guidelines.
  • Provide quality oversight on GMP documents and activities, including QA presence on the shop floor.
  • Engage in project development and customer meetings.


Basic Requirements

  • Bachelor’s degree in a scientific field (e.g., chemistry, microbiology, engineering) or equivalent.
  • At least 10 years of experience in the pharmaceutical industry.
  • Minimum of 5 years of leadership experience in Quality Assurance and Quality Control.


Additional Skills/Preferences

  • Proficiency in Microsoft Office and other computer systems.
  • Strong technical writing skills.
  • Excellent oral and written communication abilities.
  • Proven problem-solving and critical decision-making skills.
  • Ability to coach, mentor, and lead others effectively.
  • Strong interpersonal skills with the ability to influence across functions and externally.
  • Self-motivated leadership with a commitment to a fair and equitable work environment.
  • Deep understanding of cGMPs, policies, procedures, and guidelines.
  • Proven ability to maintain a safe work environment.
  • Compliance with DEA regulations.

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