Associate Director, Quality Assurance, GCP

CultureHQ

Providing strategic leadership and oversight of GCP quality assurance activities in clinical development programs. Ensuring compliance with regulatory requirements while fostering a culture of quality.

Posted 7/16/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $180,000 - $205,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GCP Quality Assurance, regulatory inspection readiness, and quality system management within the pharmaceutical or biotechnology industry. Proven ability to lead audits, manage quality investigations, and mentor junior staff while ensuring compliance with GCP regulations and guidelines.

Highest-signal resume keywords

GCP Quality AssuranceRegulatory Inspection ReadinessAudit Program ManagementQuality Investigation ManagementGCP Regulations and Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GCP AuditsQuality MetricsCAPA ManagementRegulatory SubmissionsQuality Systems DevelopmentIssue ManagementClinical Document ReviewFDA Inspection PreparationCRO OversightGCP Compliance

Soft Skills

Problem-SolvingCommunicationCollaborationMentorshipInfluencing

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryICH-GCPFDAEMASOPsQuality AssuranceClinical DevelopmentClinical OperationsQuality Events

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
Own and drive regulatory inspection readiness, including preparation for FDA and other health authority inspections, inspection conduct, and response to findings.
Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
Provide expert guidance in the identification, investigation, and resolution of quality events, including deviations, CAPAs, and audit findings.
Oversee and maintain the GCP quality systems, including processes for audit tracking, issue management, and quality metrics.
Contribute to the development, implementation, and continuous improvement of quality systems, SOPs, and policies to support GCP compliance.
Support cross-functional teams in the preparation and review of clinical documents and regulatory submissions from a quality perspective.
Manage relationships with external vendors and partners to ensure quality expectations are clearly defined and met.
Provide mentorship and guidance to junior QA staff and serve as a key quality resource across the organization.

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred.
8-10 years of experience in GCP Quality Assurance within the pharmaceutical or biotechnology industry.
Demonstrated experience leading or supporting regulatory inspections (e.g., FDA, EMA) and audit programs.
Strong understanding of GCP regulations and guidelines, including FDA, EMA, ICH-GCP, and other global regulatory requirements.
Experience working with and overseeing CROs and external vendors supporting clinical programs.
Proven ability to manage quality investigations, CAPAs, and inspection readiness activities.
Strong problem-solving skills and ability to operate effectively in a fast-paced, evolving environment.
Excellent written and verbal communication skills, with the ability to clearly communicate risks, findings, and recommendations to cross-functional stakeholders.
Ability to work independently while collaborating effectively across teams and influencing without direct authority.

Benefits

Comp & perks

100% coverage of medical, dental, and vision premiums for you and your family
Funding up to 75% of in-network deductibles
401(k) match with immediate vesting
Generous paid time off
12 weeks of fully paid parental leave
Paid family and medical leave for all employees regardless of location
Company-paid short-term disability coverage for up to 20 weeks
Wellness programs
Tuition reimbursement
Inclusive family-forming support