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 Manager, Quality Assurance 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.
Specific Duties, Activities, and Responsibilities
Provide
phase appropriate Quality Assurance guidance and support for
manufacturing, analytical and clinical operations teams
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
Manage
and support regulatory inspection efforts
Create,
revise, review and approve documentation in Quality Assurance operations,
including Batch Records, protocols, investigations, change control,
deviations, CAPAs, material release, specifications, and data review
Write,
edit, review, approve, and implement Standard Operating Procedures (SOPs)
and Quality Policies
Review
and approve validation documentation for site equipment, systems and
processes
Review
and approve raw material and final product release
Perform
internal systems and compliance audits
Manage
vendor assessments and external audits
Interface
with customers and regulatory agencies
All other duties as assigned
Education and Experience
BS degree in life science or technical discipline
8+ years of relevant work experience in a current Good Manufacturing Practices (cGMP), Good Laboratories Practices (GLP) and/or Good Clinical Practices (GCP) environment with progressive responsibilities
Experience in preparation for and support of regulatory inspections preferred
Knowledge, Skills and Abilities
Requires thorough understanding and knowledge of documentation and records management, change control and Quality system requirements in support of cGMP, GLP and/or 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 quality effort at the company
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.
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