Quality Operations Program Manager

About the Role

The Quality Operations Program Manager role ensures the integrity, compliance, and management of Veeva's processes within the Quality Management System (QMS). Serving as a process owner for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains.

What You'll Do

• Act as a subject matter expert for the Document Control process area by owning the creation and lifecycle management of quality processes and records
• 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
• 3+ 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

Nice to Have

• Direct, hands-on experience with 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)

Perks & Benefits

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

Compensation

Base pay: $85,000 - $130,000. The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.