Senior Vice President of Global Quality

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.

Location: Onsite; Morrisville, NC

Job Summary

The Senior Vice President, Global Quality is responsible for leading and overseeing all aspects of the company’s global Quality Assurance and Quality Control functions, in support of our internal and external clinical development of our global phase 3 drug-device candidate and all associative production activities, and products. The primary function of this role is to ensure and enable world-class processes, systems, and practices to assure excellence in our clinical trials and products and clear compliance with FDA and other appropriate international regulatory agency requirements, with an unwavering focus on our customers, partners, and employees. This is a visible role that requires effective leadership skills with core competences such as: collaboration, influence, and teamwork.

Qualifications

• B.S. in life sciences, engineering, or other technical discipline
• M.B.A. or related master’s degree, preferred but not required
• Minimum fifteen (15) years of relevant work experience in current Good Manufacturing Practices (cGMP),r Good Laboratory Practices (GLP), and/or Good Clinical Practices (GCP) environments with progressive responsibilities
• Proven leadership of Quality Assurance, Quality Control, Manufacturing, and/or other Life Sciences/Pharmaceutical Operations areas
• Proven leadership of preparation for and execution of regulatory inspections. Direct experience working with regulators from global agencies is preferred.
• Requires thorough experience, understanding and knowledge of all aspects of pharmaceutical quality assurance and quality control including best practices and industry trends.
• Ability to lead cross-functionally and cross-organizationally, providing clarity, consistency, and direction.
• Strong knowledge of drug development including small molecules and/or novel manufacturing processes. Experience with inhaled products and/or drug/device combination products preferred.
• Confidence and experience working directly with FDA, EMA, and appropriate global regulatory bodies in inspection and meeting settings.
• Seasoned understanding of GXP processes and global regulatory requirements with ability to move between commercial, clinical, and pre-clinical programs.
• Solid understanding / experience in various aspects of Pharmaceutical Operations including various products, dosage forms, production techniques, test methods, validation, etc.
• Demonstrate effective leadership skills, as well as aptitude for detail orientation, with strong interpersonal, oral, and written communication skills.
• Communicate with clarity and confidence to all members of the organization, across all functions and levels.
• Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving in a way that enables, teaches, and inspires others.
• Occasional travel will be required (<15%).
  
  

Responsibilities:

• Ensure continued compliance and inspection readiness of our North Carolina production and testing activities, as well as our partners’ operational and testing activities across our product supply network.
• Act as the Head of Quality for all aspects of clinical development, production/product review, product testing, and release.
• Responsible for directing investigations into product quality complaints and for determining the need for product recalls.
• Oversee the Quality Assurance and Quality Control functions of the company.
• Represent the company, as appropriate, both internally and externally, in all matters relating to our Quality Management System, including partner meetings and negotiations, Quality Agreements, and our internal and external audit programs.
• Develop, maintain, and verify effectiveness of our Quality Management System. Provide Executive Leadership with regular updates regarding the Liquidia Quality System’s effectiveness and key quality and compliance risks.
• As part of the Operations Leadership Team, work collaboratively with all leaders in and beyond operations to enable world-class practices, capabilities, and employees.
• Develop and 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.
• Ensure all documentation, records management, and operations in Quality Assurance and Quality Control comply with current global regulatory agency expectations for quality. Direct implementation of system improvements as necessary to maintain compliance and to scale with business needs.
• Interface with customers, partners, and regulatory agencies; host partner audits and regulatory inspections. Provide leadership to audit and inspection response processes.
• Ensure quality and compliance of global clinical trial operations, including clinical vendors, clinical investigator sites, and clinical trial conduct.
• Provide excellence in leadership, employee development, and cross-functional team membership, with a keen eye on talent and developing world-class teams.
  
  

Benefits

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.