Quality Operations & eDMS Program Manager

Veeva Systems; United States; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

Flexible PTO

Retirement programs

1% charitable giving

Job summary

Veeva Systems is a mission-driven SaaS leader in life sciences, offering flexible work options to thrive in your preferred environment. The Quality Operations Program Manager will own document control lifecycle, administer the eDMS, and ensure compliance across product lines within the QMS.

Strong communication and regulatory interpretation skills are essential. Requirements include a BS/BA in a relevant field, 5+ years in a regulated quality role, and experience with QMS/eDMS and GxP.

Qualifications

• BS/BA in Science, Information Management, Engineering, or related discipline or equivalent industry experience.
• 5+ years of experience in a regulated quality role in Life Sciences.
• Experience with Quality Management Systems (QMS) including documentation/records management, training, change control, CAPA.
• Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS).
• Strong understanding of GxP (GMP, GCP) and related quality frameworks (ISO9001).
• Excellent process mapping, problem-solving, and communication skills to convey technical/regulatory concepts.

Responsibilities

• Own the lifecycle management of quality processes and records as the Document Control SME.
• Serve as System Administrator of the internal eDMS, including configuration, user administration, lifecycle management, and process improvements.
• Provide quality oversight on regulated activities and deliverables (process definition, validation testing, product releases/changes).
• Offer regulatory interpretation and guidance on federal regulations and quality system requirements.
• Develop metrics and track effectiveness of domain systems.

Skills

Process mapping

Problem-solving

Communication

Education

BS/BA in Science or related field

Tools

QMS

eDMS/eQMS

Job description

Veeva Systems is a mission-driven SaaS leader in life sciences, offering flexible work options to thrive in your preferred environment. The Quality Operations Program Manager will own document control lifecycle, administer the eDMS, and ensure compliance across product lines within the QMS.

Strong communication and regulatory interpretation skills are essential. Requirements include a BS/BA in a relevant field, 5+ years in a regulated quality role, and experience with QMS/eDMS and GxP.