- 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
- 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
- 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
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Quality Assurance Manager - Morrisville, United States - Liquidia Technologies
2 weeks ago
Description
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.
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 ResponsibilitiesBenefits:
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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