Quality Operations Program Manager - Document Control

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 organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We’re not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

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 the process owner for document control, this role ensures processes are defined, monitored, assessed, and maintained across multiple product lines and regulated domains. This role also serves as system administrator for electronic Document Management System (eDMS) ensuring the delivered system aligns with quality and company goals.

What You’ll Do

• 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

Nice to Have

• 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)

Perks & Benefits

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

Compensation

• Base pay: $100,000 - $150,000
• 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.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].