Temporary GCP Quality Assurance Manager

OVERVIEW

We are currently seeking an experienced Temporary GCP Quality Assurance Manager to join a well‑known client’s team. This role supports global clinical trials by ensuring compliance with Good Clinical Practice (GCP) regulations, guidelines, and applicable legislation. The Temporary GCP Quality Assurance Manager will lead and execute quality assurance activities, including audits of clinical trials, investigator sites, systems, vendors, and documentation, while providing guidance to clinical teams on regulatory expectations. This position plays a critical role in fostering a culture of quality and inspection readiness across clinical development programs.

RESPONSIBILITIES

Quality Assurance & Compliance Provide guidance on the interpretation and application of GCP regulations and guidelines to cross‑functional clinical teams. Ensure compliance across clinical trial conduct, documentation, systems, investigator sites, and vendors. Partner with study teams to maintain a state of inspection readiness. Audit Execution & Oversight Contribute to the development of the GCP audit plan. Conduct and/or oversee audits of: Clinical investigator sites Internal GCP systems and processes External vendors (e.g., CROs) Clinical trial documentation (e.g., CSRs) Perform audits independently, including planning, execution, reporting, and presentation of findings. Identify trends, systemic issues, and opportunities for process improvement. CAPA & Risk Management Evaluate and provide input on Corrective and Preventive Action (CAPA) plans. Identify and communicate GCP non‑compliance issues and audit findings in a clear, professional manner. Support proactive risk identification and mitigation strategies for clinical programs. Inspection Readiness & Regulatory Support Support regulatory inspections by health authorities (e.g., FDA, EMA). Ensure audit readiness of systems, processes, and documentation. Collaborate with teams to address findings and maintain compliance standards. Cross‑Functional Collaboration Partner effectively with clinical, quality, and operational teams to ensure aligned execution of clinical trials. Contribute to building and sustaining a strong quality culture across the organization.

EXPERIENCE

Minimum 5+ years of experience in GCP Quality Assurance within biotech, pharmaceutical, or related industry. Demonstrated experience planning, conducting, and reporting GCP audits (sites, vendors, systems, processes). Strong working knowledge of ICH GCP (E6 R3), FDA (21 CFR), EMA, and global regulatory requirements. Experience working with CROs, vendors, and global clinical teams.

EDUCATION

Bachelor’s degree (BS/BA) in life sciences, STEM, or related field required. Equivalent combination of education and experience may be considered.

TO BE A BEST FIT, YOUR STRENGTHS MUST INCLUDE

Strong expertise in GCP regulations and clinical quality systems. Proven ability to identify and communicate compliance risks and audit findings. Excellent organizational skills with the ability to manage multiple priorities in a fast‑paced environment. Strong collaboration and negotiation skills across cross‑functional teams. Ability to work both independently and within a team‑oriented environment. Excellent written, verbal, and presentation skills. Strong attention to detail with a commitment to quality and compliance excellence.

ADDITIONAL DETAILS

Travel: Approximately 30% travel required Benefits and Employment Full‑time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits. Equal Employment Opportunity Statement At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status or any other basis protected by applicable federal, state or local law. Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact View email address on click.appcast.io. #J-18808-Ljbffr Advanced Clinical