Audit Program Manager

About the role

This role involves leading and participating in audit processes within the life sciences sector. You will be responsible for hosting customer audits, documenting observations, and crafting responses. A key part of the job includes conducting internal audits according to the annual plan and supporting regulatory inspections, ensuring all activities align with compliance standards.

The position also requires managing information requests from various internal and external groups, delivering compliance presentations, and collaborating with other departments on third-party audits. You will contribute to document reviews and provide general compliance support for the business, including administering the Quality Management System (QMS).

Success in this role means effectively navigating complex regulatory landscapes, maintaining strong relationships with stakeholders, and ensuring Veeva Systems upholds its commitment to quality and compliance. You will contribute to the company's mission of accelerating therapies to patients by maintaining rigorous audit and inspection management practices.

The base salary for this position ranges from $51,750 to $86,250, with actual salaries depending on experience and location.

Skills that matter here

• audit management: This role requires conducting internal audits, hosting customer audits, and supporting regulatory inspections.
• compliance: A primary function is to ensure adherence to regulations in the life sciences sector and provide compliance support to the business.
• quality processes: The role involves documenting audit findings, administering the QMS, and understanding quality principles in software development.
• regulatory intelligence: Candidates need a good understanding of GxP, ICH, and ISO frameworks relevant to life sciences.
• ISO9001: Experience with ISO frameworks is required, particularly in the context of quality principles and standards.
• Microsoft applications: Proficiency in Microsoft applications like Excel and PowerPoint is needed for documentation and presentations.

Who this role suits

• Someone with a background in science, engineering, or information management, or equivalent work experience.
• A professional with at least three years in a regulated quality or compliance role, ideally within life sciences.
• An individual who excels at customer service and collaboration, with strong communication skills.
• A candidate who has experience hosting audits or participating in regulatory inspections as a subject matter expert.

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.