GCP Quality Manager

Job Title:

GCP Quality Manager The GCP Quality Manager leads and executes Good Clinical Practice (GCP) quality assurance activities to support global clinical trials. This role partners cross-functionally with clinical teams to ensure trials, systems, vendors, and documentation comply with ICH GCP and applicable regulations. The GCP Quality Manager develops and delivers GCP audit plans, conducts or oversees a wide range of GCP audits, supports regulatory inspections, and helps build a strong, sustainable quality and inspection-ready culture across the organization. Responsibilities Partner cross-functionally with clinical and functional teams to support the compliant and successful execution of clinical trials. Contribute to the development and maintenance of the GCP audit plan for global clinical studies, systems, and vendors. Conduct and/or oversee audits of clinical investigator sites, including preparation, on-site or remote execution, and follow-up reporting. Perform audits of internal GCP systems, processes, and procedures to assess compliance with ICH GCP and applicable regulations. Plan and execute audits of external vendors, such as contract research organizations (CROs), and other service providers involved in clinical trial execution. Audit clinical trial documents, including but not limited to clinical study reports (CSRs), to verify accuracy, completeness, and regulatory compliance. Independently manage the full audit lifecycle, including audit preparation, conduct, documentation, presentation of findings, and issuance of audit reports. Identify systemic issues, trends, and areas for improvement in GCP compliance, and clearly communicate findings to relevant stakeholders. Report significant quality and compliance issues and propose practical, risk-based improvement opportunities in collaboration with senior auditors or management as needed. Assist in the assessment and evaluation of proposed Corrective and Preventive Action (CAPA) plans to ensure they address root causes and are feasible and effective. Monitor the implementation and effectiveness of CAPA actions related to GCP findings and escalate issues when necessary. Support GCP-related Regulatory Authority inspections by preparing documentation, coordinating responses, and participating in inspection activities. Provide guidance and support to clinical teams on the interpretation and application of GCP regulations, ICH guidelines, and local legislation. Partner with study teams to promote and embed a strong quality culture and a sustained state of inspection readiness across clinical programs. Contribute to continuous improvement of GCP quality systems, processes, and tools to enhance efficiency and compliance. Collaborate with internal stakeholders and external partners to ensure alignment with GCP expectations and regulatory requirements. Essential Skills Established knowledge and hands-on experience with Good Clinical Practice (GCP) regulations, guidelines, and local legislation. Solid knowledge of

ICH GCP E6

(R3) and the ability to apply this knowledge to support clinical trial activities. Working knowledge of FDA, EMA, and ICH GCP guidelines and related GCP regulations, including applicable 21 CFR requirements. Proven experience leading and executing GCP quality assurance activities in support of global clinical trials. Demonstrated ability to plan, conduct, and report all types of GCP audits, including investigator site audits, process audits, vendor audits, and document audits. Experience working with contract research organizations (CROs) and other external vendors involved in clinical research. Ability to interpret and apply GCP regulations and guidelines to real-world clinical trial scenarios and provide clear compliance guidance. Strong analytical skills to identify systemic issues, assess risks, and propose effective corrective and preventive actions. Excellent communication skills to present audit findings, collaborate with cross-functional teams, and interact with regulatory and inspection stakeholders. BS/BA degree, preferably in life sciences or STEM disciplines, or an equivalent combination of education and experience. Required minimum of 5 years of related experience in the biotechnology, pharmaceutical, or related industry. 10-20 years of related overall experience, or an equivalent combination of education and experience, in GCP quality, clinical operations, or related functions. Additional Skills & Qualifications Experience supporting GCP Regulatory Authority inspections, including preparation, participation, and follow-up activities. Experience contributing to the development and maintenance of a GCP audit plan for global clinical programs. Background in life sciences or STEM disciplines that supports a strong understanding of clinical research and development. Ability to foster a culture of quality and continuous improvement within clinical and cross-functional teams. Comfort working in a global, matrixed environment with multiple stakeholders and competing priorities. Strong organizational and time management skills to manage multiple audits and quality activities simultaneously. Proficiency in documenting, tracking, and reporting audit outcomes and CAPA activities in a clear and structured manner. Work Environment The GCP Quality Manager works in a professional, highly regulated environment focused on the planning and execution of global clinical trials. The role involves extensive collaboration with clinical development, clinical operations, quality assurance, and external partners such as contract research organizations. Work is primarily office-based or remote-office based, using standard business and quality systems to plan audits, document findings, and manage quality activities. The position requires careful attention to detail, adherence to GCP and regulatory expectations, and readiness to support regulatory inspections and audits as needed. Job Type & Location This is a Contract position based out of San Francisco, CA. Pay and Benefits The pay range for this position is $80.00 - $95.00/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.

Application Deadline This position is anticipated to close on Jul 3, 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.