Audit Program Manager

About the role

In this role, you will manage customer and regulatory audits, document findings, and conduct internal audits. You will collaborate with various internal departments and support compliance outreach efforts, ensuring adherence to industry regulations.

Veeva Systems is a pioneer in the life sciences sector, committed to its mission of helping companies bring therapies to patients faster. As a middle-seniority position, this role is integral to maintaining the quality and compliance standards that are essential in this highly regulated industry.

The salary range for this role is $51,750 to $86,250, depending on experience and qualifications.

Skills that matter here

• audit management: The role involves hosting audits and managing audit documentation.
• compliance: You will support compliance outreach and ensure adherence to industry standards.
• quality processes: The position requires a strong understanding of quality principles in regulated environments.
• regulatory intelligence: You will need to understand regulations relevant to the life sciences sector.
• ISO9001: Experience with ISO frameworks is essential for managing audits.
• Microsoft applications: Proficiency in Microsoft tools is necessary for documentation and presentations.

Who this role suits

• A candidate with a background in science or engineering, ideally with experience in regulated environments.
• Someone who values collaboration and has strong customer service skills.
• An individual who thrives in a flexible work environment and can manage multiple stakeholders effectively.
• A professional with a proactive approach to compliance and quality assurance.

From the employer

What You'll Do:

• Hosts customer audits and supports regulatory audits
• Documents audit findings and authors audit response in relation to customer audit observations
• Conducts internal audits in support of the annual audit plan
• Manages informational requests for internal and external stakeholders
• Performs compliance outreach presentations
• Supports and coordinates with internal departments related to third-party audits (e.g. SOC, ISO)
• Document review
• Compliance support for the business
• QMS system administration

Requirements:

• BS/BA in Science, Engineering, Information Management, related disciplines or equivalent work experience
• 3+ years experience in a regulated quality / compliance role
• Good understanding of regulations in the life sciences sector, either GxP (GMP, GCP, etc.) and/or ICH & ISO frameworks
• Experience hosting audits and/or regulatory inspections or participating in as a subject matter expert
• Excellent customer service skills with a strong focus on collaboration
• Good knowledge of Microsoft applications (e.g., MS Excel, MS PowerPoint)
• Strong verbal and written communication skills

Nice to Have:

• 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)
• 2+ years in an audit specific role in life sciences
• Veeva products experience
• Understanding of computer system validation
• Understanding of best practices in information security and risk management

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.