Quality Operations Program Manager - Document Control

Posted 2 Days Ago
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Hiring Remotely in Boston, MA, USA
In-Office or Remote
100K-150K Annually
Senior level
Big Data • Cloud • Healthtech • Software • Big Data Analytics
The software company powering the path to the world’s new medicines.
The Role
Own document control within the Quality Management System, serve as eDMS system administrator, ensure compliance with GxP/regulatory requirements, provide quality oversight for regulated activities, and track metrics for continuous improvement.
Summary Generated by Built In
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.

#LI-RemoteUS#LI-Associate


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 [email protected].

Skills Required

  • BS/BA in Science, Information Management, Engineering, related discipline or equivalent experience
  • 5+ years experience in a regulated quality role in Life Sciences
  • Experience with Quality Management Systems (documentation/record management, training, change control, CAPA)
  • Experience with electronic Document Management Systems (eDMS) and/or electronic Quality Management Systems (eQMS)
  • Good understanding of GxP regulations and quality system principles (21 CFR Part 11, ICH Q10, QSR) or ISO9001
  • Excellent process mapping, problem-solving, and communication skills
  • Hands-on experience administering Veeva Quality Cloud solutions (Veeva QualityDocs, QMS, Training)
  • Foundation in quality principles/standards for regulated software (ISO, IEC, IEEE, ITIL, ICH)
  • Understanding of the software development lifecycle (SDLC) and computer systems validation (CSV)

Veeva Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Veeva and has not been reviewed or approved by Veeva.

  • Equity Value & Accessibility Equity is broadly distributed across the company, positioning most employees as shareholders. Stock-based incentives can materially enhance total compensation, particularly at higher seniority.
  • Flexible Benefits Work Anywhere enables remote-first flexibility with options to use offices and to gather through offsites or coworking weeks. This structure supports collaboration while minimizing rigid on-site requirements.
  • Healthcare Strength Core coverage includes medical, dental, vision, HSA/FSA, life and disability, and EAP. Supplemental perks such as commuter assistance and wellness or gym reimbursements are available in some locations.

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The Company
HQ: Pleasanton, CA
6,000 Employees
Year Founded: 2007

What We Do

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.

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