Liquidia Corporation
Quality Assurance Manager, Quality Systems
Liquidia Corporation, Morrisville, North Carolina, United States, 27560
Quality Assurance Manager, Quality Systems
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Quality Assurance Manager, Quality Systems
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Liquidia Corporation Quality Assurance Manager, Quality Systems
Join to apply for the
Quality Assurance Manager, Quality Systems
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Liquidia Corporation Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Liquidia Corporation 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 Systems is responsible for overseeing and continuously improving a compliant and effective quality management system. This role involves a variety of activities to ensure adherence to regulatory requirements, company policies, and procedures. Responsibilities include managing quality systems, leading management review boards, developing and delivering training, authoring documents, and tracking/reporting metrics. Responsibilities Maintain the Quality Management System (QMS), ensuring compliance with applicable regulations. Ensure timeliness of Quality System closures (e.g. deviations, change controls and CAPAs). Develop and administer the activities of the quality management boards, including the Change Control Board, and other Quality Management Review (QMR) meetings. Develop and report metrics to support QMR and KPls to monitor QMS performance. Proactively identify areas for improvement and collaborate cross-functionally on continuous improvement initiatives. Serve as the subject matter expert on the electronic quality systems and maintain a thorough understanding of system capabilities to provide support to record owners. Assists in and prepare for regulatory agency inspections Lead the training management program by designing and maintaining curriculums across multiple departments. Perform company-wide cGxP and Electronic QMS training on an as-needed basis. Proactively identify areas for improvement and collaborate cross-functionally on continuous improvement initiatives. Apply a risk-based approach to decision-making, guidance, and issue mitigation. Perform other duties as assigned Requirements Education and Experience Bachelor's degree in relevant discipline. Minimum 5 years pharmaceutical/biotechnology experience in Quality Assurance/Systems, supporting GxP (GCP, GMP, GLP). Minimum 2 years' experience leading a team. Knowledge, Skills, and Abilities In-depth knowledge of FDA regulations and ICH Guidelines, as well as experience with international regulations and guidelines. Knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions. Ability to author and review multiple types of documents, with strong attention to detail. Excellent verbal and written communication skills, with the ability to collaborate effectively with employees at all levels. Experience in implementing and managing electronic Quality Management Systems (eQMS). 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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance and Management Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Liquidia Corporation by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Quality Assurance Manager” roles.
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Join to apply for the
Quality Assurance Manager, Quality Systems
role at
Liquidia Corporation Quality Assurance Manager, Quality Systems
Join to apply for the
Quality Assurance Manager, Quality Systems
role at
Liquidia Corporation Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Liquidia Corporation 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 Systems is responsible for overseeing and continuously improving a compliant and effective quality management system. This role involves a variety of activities to ensure adherence to regulatory requirements, company policies, and procedures. Responsibilities include managing quality systems, leading management review boards, developing and delivering training, authoring documents, and tracking/reporting metrics. Responsibilities Maintain the Quality Management System (QMS), ensuring compliance with applicable regulations. Ensure timeliness of Quality System closures (e.g. deviations, change controls and CAPAs). Develop and administer the activities of the quality management boards, including the Change Control Board, and other Quality Management Review (QMR) meetings. Develop and report metrics to support QMR and KPls to monitor QMS performance. Proactively identify areas for improvement and collaborate cross-functionally on continuous improvement initiatives. Serve as the subject matter expert on the electronic quality systems and maintain a thorough understanding of system capabilities to provide support to record owners. Assists in and prepare for regulatory agency inspections Lead the training management program by designing and maintaining curriculums across multiple departments. Perform company-wide cGxP and Electronic QMS training on an as-needed basis. Proactively identify areas for improvement and collaborate cross-functionally on continuous improvement initiatives. Apply a risk-based approach to decision-making, guidance, and issue mitigation. Perform other duties as assigned Requirements Education and Experience Bachelor's degree in relevant discipline. Minimum 5 years pharmaceutical/biotechnology experience in Quality Assurance/Systems, supporting GxP (GCP, GMP, GLP). Minimum 2 years' experience leading a team. Knowledge, Skills, and Abilities In-depth knowledge of FDA regulations and ICH Guidelines, as well as experience with international regulations and guidelines. Knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions. Ability to author and review multiple types of documents, with strong attention to detail. Excellent verbal and written communication skills, with the ability to collaborate effectively with employees at all levels. Experience in implementing and managing electronic Quality Management Systems (eQMS). 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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance and Management Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Liquidia Corporation by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Quality Assurance Manager” roles.
Supervisor - Quality Assurance Floor Support (Day Shift)
Senior Clinical Quality Assurance Manager
Quality Assurance Manager, Product Complaints
Durham, NC $125,000.00-$150,000.00 3 weeks ago Supervisor - Quality Assurance Floor Support (Night Shift)
Supervisor - Quality Assurance Floor Support (Day Shift)
Supervisor - Quality Assurance Floor Support (Night Shift)
Quality Assurance Operations Engineer DSM - Night
Project Manager- Electrical Contractor (copy)
Raleigh, NC $98,000.00-$105,000.00 21 hours ago Food Safety and Quality Assurance Manager/Preston
Quality Control Manager, Federal (Traveler)
Principal Quality Engineer/Manager (Business Systems) - Remote
HRIS Business Systems Administrator - Oracle
Medical Lab Scientist, Advanced - Blood Gas Lab - First Shift
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr