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.
