Director Of GxP Quality

Job Title: Director, QA Compliance

The Director of QA Compliance will lead the commercial QA Compliance function and ensure ongoing inspection readiness across audits, supplier quality, regulatory inspections, management review, and quality-related licenses. This role involves providing strategic Quality Systems oversight and collaborating cross-functionally to identify, escalate, and resolve compliance risks.

Responsibilities

• Lead QA Compliance governance and maintain continuous inspection-readiness across commercial Quality Systems.
• Manage internal, clinical, and supplier audit programs, including planning, execution, reporting, CAPA follow-up, effectiveness checks, and risk-based prioritization.
• Oversee supplier qualification, periodic review, quality agreements, performance monitoring, issue escalation, and remediation tracking.
• Serve as quality lead for regulatory inspections, involving readiness planning, hosting support, response coordination, commitment tracking, and remediation.
• Support Management Review and Quality Council forums through metrics, trend analyses, risk assessments, and executive-level compliance summaries.
• Monitor regulatory intelligence and translate global regulatory changes and enforcement trends into practical Quality System updates.
• Lead or oversee compliance activities, quality trend reviews, compliance metrics, and process improvements to enhance QMS effectiveness and scalability.

Essential Skills

• BIMO Experience
• Bachelor’s degree in life sciences, pharmacy, chemistry, biology, engineering, or a related scientific discipline; advanced degree preferred.
• 15 years of progressive experience in Quality Assurance, Quality Compliance, or Quality Systems in pharmaceutical, biotechnology, or regulated life sciences.
• Prior leadership experience at Manager, Senior Manager, Associate Director, or Director level in commercial Quality Systems or QA Compliance programs.
• Experience with commercial-stage quality systems including audits, management review, metrics, inspection readiness, and supplier oversight.
• Working knowledge of FDA, EMA, PMDA preferred.
• Familiarity with ICH, GxP, GMP, GCP, and commercial quality requirements, focusing on inspection support and regulatory submission QC/Support.
• Excellent written and verbal communication skills, with the ability to present complex compliance topics to Senior leaders and cross-functional stakeholders.

Work Environment

This position is remote, with a preference for candidates located on the East Coast, but flexibility is available for highly qualified individuals. The role offers an opportunity to lead and develop a commercial QA Compliance function with broad ownership across audit programs, supplier quality, inspection readiness, and management review. It is a high-visibility leadership role with exposure to Senior stakeholders, cross-functional partners, and regulated third-party networks

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

The pay range for this position is $125.00 - $135.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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 Sep 11, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $125 - $135