Quality Operations Program Manager - Document Control

About the role

Act as subject matter expert for the Document Control process area by owning the lifecycle management of quality processes and records.
Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the system and its governed processes.
Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems.
Provide technical expertise, regulatory interpretation, and direction regarding federal regulations, and other quality system requirements.
Develop appropriate metrics and track effectiveness and productivity of applicable domain systems.

Responsibilities

• Act as subject matter expert for the Document Control process area by owning the lifecycle management of quality processes and records
• Serve as System Administrator of Veeva’s internal electronic Document Management System (eDMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the system and its governed processes
• Provide quality oversight on regulated activities and deliverables, such as process definition, validation testing, and product releases/changes for in scope products and systems
• Provide technical expertise, regulatory interpretation, and direction regarding federal regulations, and other quality system requirements
• Develop appropriate metrics and track effectiveness and productivity of applicable domain systems

Requirements

• BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
• 5+ years experience in a regulated quality role in Life Sciences
• Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
• Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001
• Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts
• Direct, hands-on experience utilizing or administering Veeva Quality Cloud solutions (e.g., Veeva QualityDocs, QMS, or Training)
• Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
• Understanding of the software development cycle (SDLC) and computer systems validation (CSV)

Qualifications

• BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
• 5+ years experience in a regulated quality role in Life Sciences
• Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
• Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001
• Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts
• Direct, hands-on experience utilizing or administering Veeva Quality Cloud solutions (e.g., Veeva QualityDocs, QMS, or Training)
• Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
• Understanding of the software development cycle (SDLC) and computer systems validation (CSV)

Skills

• BS/BA in Science, Information Management, Engineering, related disciplines or equivalent industry experience
• 5+ years experience in a regulated quality role in Life Sciences
• Experience with Quality Management Systems (e.g., documentation and record management, training, change control, CAPA)
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
• Good understanding of GxP (GMP, GCP, etc.) regulations, principles of quality management systems in a regulated environment (21CFR 11, ICH Q10, QSR) and/or quality frameworks such as ISO9001
• Excellent process mapping, problem-solving, and communication skills to effectively convey technical and regulatory concepts
• Direct, hands-on experience utilizing or administering Veeva Quality Cloud solutions (e.g., Veeva QualityDocs, QMS, or Training)
• Solid foundation in Quality Principles and Standards used in the design, development, testing, and maintenance of software in a regulated environment (e.g., ISO, IEC, IEEE, ITIL, ICH)
• Understanding of the software development cycle (SDLC) and computer systems validation (CSV)

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retailer retirement programs
• 1% charitable giving program

Pay

Base pay: $100,000 - $150,000

Schedule

Not specified