GxP Auditor

The GxP Auditor will provide essential support for the vendor management and audit program. This role is pivotal in ensuring compliance with FDA, ICH, and global requirements while supporting the integration of acquired programs and driving continuous improvements in quality systems.

Responsibilities

• Execute the annual GCP/GVP audit plan by leading vendor audits and reviewing questionnaires.
• Manage audit issue resolution and maintain the audit observation database, delivering metrics and trend analyses to leadership.
• Oversee GxP vendor lifecycle management, including risk assessments, initial qualification, requalification, and maintenance of the Approved Vendor List.
• Serve as a key QA point of contact for vendor-related audits, performance oversight, and compliance decision-making.
• Provide support during GxP health authority inspections.
• Support development and maintenance of GxP quality documentation, including SOPs, policies, templates, and work instructions.
• Oversee maintenance of clinical site and vendor quality documentation archives.

• Bachelor’s degree in Life Sciences with 10 years in pharmaceutical or biotech drug development. Advanced degree preferred.
• Minimum 5 years of experience in GCP/GVP, including both external and internal auditing.
• Extensive experience with Global Clinical trial conduct and a thorough understanding of ICH E6 GCP Guideline and FDA Regulations.
• Previous experience facilitating and/or supporting Regulatory Authority Inspections.
• Previous experience in development and oversight of Quality Management Systems.
• Excellent interpersonal skills, personal integrity, and professional manner.

• GLP vendor management experience is a plus.
• Ability to develop good working relationships with cross-functional personnel at all levels.

This position requires up to 25% travel, both domestic and international. Outside of travel requirements, the role will be remote.

Job Type & Location

This is a Contract position based out of Bedford, MA.

The pay range for this position is $100.00 - $120.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on May 8, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $100 - $120