Associate Director, Quality Assurance, GCP

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🕒 vor 15 Tagen

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $180.000 - $205.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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CultureHQ

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1 - 10 Mitarbeiter

Gegründet 2017

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Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• 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