Senior Manager, Quality Management Systems (QMS)
- Employer
- a Pharmaceutical company located in Redwood City, CA
- Location
- Redwood City, CA
- Closing date
- Jan 16, 2022
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Senior Manager, Quality Management Systems (QMS)
RESPONSIBILITIES
QUALIFICATIONS
EDUCATION
RESPONSIBILITIES
- Responsible for the development, implementation, and maintenance of the company's internal GxP quality systems (paper and electronic).
- Leading the Quality Management System (QMS) continuous improvement efforts and electronic Quality Management Systems (eQMS) enhancement efforts
- Acting as system super-user, globally assess impact of system changes to existing modules
- Managing the maintenance of SOPs, training programs, deviations, CAPAs, commercial/investigational product complaints, vendor qualification/auditing, and the documentation of these activities in the QMS
- Supporting QMS regulatory agency inspection readiness and assist during inspections
- Developing and maintaining systems for efficiently and securely storing GxP training materials, records, and documents while supporting commercial and development activities
- Assisting in Quality Systems management of QA Operations, Pharmacovigilance, and Clinical QA activities including the scheduling of GPVP and GxP internal and vendor audits and resolution of findings
- Managing periodic reviews of eQMS; resolve and document discrepancies
- Coordinating and supporting vendor support release activities
- Coordinating and resolving issues with software/consulting vendors
- Supporting and providing guidance to cross functional groups with system implementation projects
QUALIFICATIONS
- Minimum 10+ years' experience in the development and maintenance of quality systems in commercial-stage pharmaceutical companies
- Familiarity with ICH 10 & GAMP 5
- Hands on experience with QMS system implementations
- Skills, Qualifications, or Technical Proficiencies
- Experience in developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations
- Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical, and commercial products
- Proficiency in the use of Veeva QualityDocs / QMS and ComplianceWire
- Ability to manage external software and consultant vendors
EDUCATION
- Bachelors' degree in a scientific field
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