Director, Clinical Quality Assurance Consultant

Title: Director, Clinical Quality Assurance Consultant

Location: Gaithersburg United States

Job Description:

Responsibilities

• Lead CQA oversight for assigned studies, ensuring compliance with Good Clinical Practice (GCP) in collaboration with Clinical Development and CROs.
• Oversee and execute CQA audit planning and perform GCP and PV audits of investigator sites, CROs, and electronic system providers (SAAS).
• Support Clinical Operations in the assembly, maintenance, and archiving of study Trial Master Files (TMFs) and systems.
• Ensure ongoing qualification of GCP and Good Pharmacovigilance Practice (GVP) vendors and systems.
• Prepare and negotiate Quality Agreements with CROs, where applicable.
• Manage study, GCP and GVP deviations, quality issues, Corrective and Preventive Actions (CAPA), effectiveness checks, and root cause analysis.
• Direct Serious Breach processes and reporting.
• Partner with GxP functions to ensure alignment within the QMS and regulatory compliance.
• Participate in and assist in the preparation for regulatory inspections (e.g., BIMO) of sponsors, CROs, and investigator sites, based on risk.
• Advise stakeholders on GCP and GVP compliance issues.
• Prepare Key Performance Indicators (KPIs) for performance monitoring and Management Oversight.
• Contribute to the development and approval of CQA, GCP, and GVP Standard Operating Procedures (SOPs).
• Assist in providing GCP training to staff.
• Support departmental GxP activities and projects.

Essential Skills

• 8+ years or MS/PhD degrees with 6+ years of leadership experience in biopharmaceutical quality assurance and CQA.
• In-depth knowledge of Good Clinical Practices (GCP), and other applicable regulations and standards.
• Experience preparing for, conducting, and hosting regulatory inspections.
• Experience developing, implementing, and maintaining quality systems and procedures.
• Excellent leadership, communication, interpersonal, and problem-solving skills.
• Ability to work independently and as part of a cross-functional team.

Additional Skills & Qualifications

• Experience in late-stage clinical/commercial settings.
• Experience working in a clinical-stage biotech or pharmaceutical environment.
• Experience supporting early-phase and/or late-stage clinical development programs.
• Experience building or scaling QA infrastructure in a growing organization.
• Familiarity with TMF, CTMS, eQMS, Pharmacovigilance, and clinical documentation systems.
• Experience in complex therapeutic areas or innovative modalities (e.g., biologics, cell/gene therapy).

Work Environment

This role offers the opportunity to be part of a small, scaling biotech, with direct interaction with leadership, clinical operations, and manufacturing. You will have the ability to shape quality strategy, not just execute SOPs, and gain exposure across trial design, execution, and inspection readiness. The position is preferred to be based in Maryland with on-site access, but remote work is considered. Expect approximately 40% travel to sites/CROs. The company fosters a small, close-knit culture

Job Type & Location

This is a Contract position based out of Gaithersburg, MD.

Pay and Benefits

The pay range for this position is $90.00 - $125.00/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)

Workplace Type

This is a fully remote position.

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.