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Associate Director Gcp Jobs (NOW HIRING)

AstraZeneca

Local Study Associate Director

Wilmington, DE

$32.50 - $44.50/hr

... ICH-GCP and local regulations. From feasibility and site selection through monitoring and ... Study Associate Director plays a central role in turning innovative oncology science into robust ...

Parexel

OR · On-site

$33.50 - $45.75/hr

The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to ... GCP as well as relevant local regulations. The LSAD may perform site monitoring as needed to ...

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Associate Director Gcp information

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$27K

$141.2K

$310.5K

How much do associate director gcp jobs pay per year?

As of Jun 9, 2026, the average yearly pay for associate director gcp in the United States is $141,209.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,000.00 and $212,500.00 per year, depending on experience, location, and employer.

What are some common challenges faced by an Associate Director GCP, and how can these be addressed?

An Associate Director GCP often encounters challenges related to ensuring compliance with evolving global regulatory standards, managing cross-functional teams, and overseeing multiple clinical trials simultaneously. Navigating differences in international regulations and balancing competing priorities can be demanding. Building strong communication channels, staying updated on regulatory changes, and fostering a culture of quality and collaboration within the team are effective strategies for overcoming these challenges. Proactive planning and ongoing training are also key to maintaining compliance and operational efficiency.

What are the key skills and qualifications needed to thrive as an Associate Director GCP, and why are they important?

To thrive as an Associate Director GCP, you need in-depth knowledge of Good Clinical Practice (GCP) guidelines, clinical trial management, and typically an advanced degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and relevant certifications such as GCP or Project Management Professional (PMP) are highly valuable. Strong leadership, problem-solving, and communication skills set outstanding candidates apart in guiding cross-functional teams and ensuring regulatory compliance. These capabilities are essential for maintaining the integrity of clinical research and ensuring trials meet regulatory and ethical standards.

What is the difference between Associate Director Gcp vs Clinical Project Manager?

AspectAssociate Director GcpClinical Project Manager
CredentialsTypically requires advanced degrees (e.g., MD, PhD, or MSc) and GCP certificationUsually holds a bachelor's or master's degree with GCP certification
Work EnvironmentStrategic oversight, cross-functional leadership, and regulatory complianceOperational management of clinical trials, site coordination, and project execution
Industry UsageUsed in pharmaceutical and biotech companies overseeing GCP compliance at a senior levelCommonly employed in clinical research organizations and pharma for trial management

The Associate Director Gcp focuses on strategic, regulatory, and compliance aspects of clinical trials, often overseeing multiple projects and teams. In contrast, the Clinical Project Manager handles day-to-day trial operations, ensuring projects stay on schedule and within scope. Both roles require GCP knowledge but differ in scope and seniority.

What does an Associate Director GCP do?

An Associate Director GCP (Good Clinical Practice) is responsible for overseeing clinical trials to ensure they comply with regulatory standards and ethical guidelines. This role typically involves managing clinical quality assurance activities, developing and implementing GCP compliance programs, and leading audits or inspections. The Associate Director works closely with clinical teams, regulatory agencies, and external partners to guarantee that all processes align with global GCP standards. They also provide training and guidance to staff to maintain high-quality clinical research practices.
Infographic showing various Associate Director Gcp job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $141,209 per year, or $67.9 per hour.
Associate Director, GCP QA

Associate Director, GCP QA

Mirum Pharmaceuticals

Foster City, CA • Hybrid

$190K - $205K/yr

Other

Posted 4 days ago

Job description

POSITION SUMMARY

The Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum's clinical study programs as the GCP-QA representative on the study management team; managing activities involving GCP quality assurance and compliance with applicable regulatory requirements; development and implementation of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. Additionally, this position will support GVP and GLP QA operational activities to ensure data integrity and meeting regulatory expectations and industry standards. 

This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.

JOB FUNCTIONS/RESPONSIBILITIES

  • Achieve established timelines for deliverables.
  • QA Representative for assigned Mirum's Program's Clinical Study Management Teams.
  • Manage/Support BIMO inspection readiness activities
  • Support GCP/GCLP/GVP internal audits.
  • Provide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
  • Support GCP, GCLP and GVP Vendor Management/Audit Program. Ad hoc audits may be requested.
  • Assist with planning and supporting Clinical Site Management/Audit Program. Ad hoc site audits may be requested.
  • Assist with and support regulatory agency inspections for the GCP and PV impacted functions.
  • Provide GCP/GCLP/GVP Training as necessary
  • Support Quality Management Team (QMT) by providing monthly/quarterly updates based on role and responsibilities
  • Support process improvement of QA department, KPI/QPI tracking and oversight.
  • Manage GCP/GVP/GLP consultant(s) as needed

QUALIFICATIONS

Education /Experience:

  • Bachelor's Degree in a scientific discipline.
  • 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
  • Knowledge and demonstrated experience in the applicable GCP regulations, FDA Regulations and Good Clinical Practices, EMA EudraLex Regulations, and ICH Guidelines.
  • Strong verbal and written communication.
  • Knowledge of basic GVP, GCLP and GLP regulations.

The salary range for this position is $190,000 to $205,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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