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Liquidia

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.

Associate Director, Clinical Quality

Clinical OperationsClinical OperationsOtherRemoteLeadTeam 51-200

Location

United States

Posted

129 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Associate Director, Clinical Quality

Liquidia

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. Job Summary The Associate Director, Clinical Quality is responsible for providing strategic and operational GCP quality oversight across assigned clinical programs. This role partners closely with clinical teams and stakeholders to ensure continuous inspection readiness, protect subject safety, and maintain data integrity throughout the clinical trial lifecycle. Acting as a trusted quality advisor, the position delivers expert guidance on global GCP regulations, drives risk‑based decision‑making, and proactively identifies and mitigates compliance risks. The role leads complex audits, supports health authority inspections, manages investigations into significant quality issues, and ensures timely and effective corrective actions, while fostering a strong culture of quality, accountability, and collaboration across the organization. Additional responsibilities include SOP writing and reviews, gap assessments, vendor oversight, training development, and mentoring less experienced QA team members. Education and Experience: - At least 10 years of experience in pharma, biotech, or related healthcare industries - Minimum 7 years in GCP Quality Assurance at a Sponsor or CRO - Global study experience in Phase I-III clinical trials, late stage experience is a plus - Therapeutic experience in rare cardiopulmonary diseases like pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) preferred Knowledge Skills and Abilities - In-depth knowledge of ICH GCP and global clinical trial regulations - Experience working with Global Data Protection requirements and reporting - Advanced vendor and clinical site auditing expertise, including translating findings into risk-mitigating action plans - Excellent communication, technical writing, negotiation, and teamwork skills - Strong analytical abilities, sound judgment, and effective project management under tight timelines - Oversee quality assurance for Liquidia’s clinical study programs working across multiple business units, focusing on continuous inspection readiness and compliance - Quality reviewer for study related documentation as applicable (e.g. Protocols, ICFs, Study Plans, etc.) - Act as a strategic quality advisor, partnering with clinical teams and stakeholders to guide risk-based decisions in research quality - Provide expert GCP compliance guidance, training, and recommendations to program teams and leadership - Develop, implement, and manage risk-based audit strategies and conduct complex audits in line with GCP and Liquidia policies - Assess and escalate compliance risks impacting subject safety, data integrity, or business operations to management - Ensure completion of timely audit reports and corrective actions, tracking effectiveness and regulatory reporting as needed - Manage and lead investigations into significant GCP quality issues, ensuring root cause analysis and effective corrective actions - Monitor studies on assigned programs for global data protection compliance - Support and manage GCP health authority inspections, guiding teams in preparation, response, and follow-up activities - Collaborate with Quality teams to identify, analyze, and address GCP compliance issues and present key metrics and recommendations to management 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.

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Director, Clinical Operations

Liquidia

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.

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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 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. Job Summary The Director, Clinical Operations will oversee the planning, execution, and delivery of clinical trials, initially focusing on our Yutrepia program, ensuring alignment with corporate goals and regulatory requirements. You will lead and closely work closely with internal and external stakeholders to bring transformative therapies to market with this new drug device combo treatment. 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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.

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