Director, Clinical QA
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
The Director of Clinical QA is responsible for overseeing assigned activities within the Quality Assurance department. The primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as customer and internal company quality systems requirements.
Principal Duties and Responsibilities:
- Provide phase appropriate Quality Assurance guidance and support for clinical operations team.
- Manage corporate processes that maximize efficiency and phase-appropriate compliance while maintaining compliance with FDA and other regulatory agency requirements; identify improvement opportunities and effective strategies for implementation.
- Write, edit, review and approve documentation in Quality Assurance operations, including audit reports and clinical trial related quality management plans.
- Perform internal systems and compliance audits to assess compliance with GCP requirements and investigational plans.
- Manage vendor assessments and external audits for clinical operations vendors, including clinical research organizations, investigator sites, depots and laboratories.
- Provide phase appropriate oversight of risk management in support of clinical operations.
- Supports the management and resolution of significant quality issues.
- Manage Qualified Person(s) interaction, when required, to ensure release of material for clinical trials.
- Interface with regulatory agencies when required.
- All other duties as assigned.
- BS degree in life science or technical discipline.
- 8+ years of relevant work experience in a current Good Clinical Practices (GCP) environment with progressive responsibilities.
- Experience in preparation for and support of regulatory inspections preferred.
- Requires thorough understanding and knowledge of documentation and records management, and Quality system requirements in support of GCP regulations.
- Ability to organize time for multiple tasks in a dynamic environment.
- Ability to work effectively under matrix organization with multiple deadlines.
- Detail oriented with strong interpersonal, oral and written communication skills.
- Work proactively to lead the clinical quality effort at the company.
- Ability to travel 15-25%.
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note:
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.