Senior Manager, Clinical Quality Assurance
J
JobgetherPharmaceutical drug development
Remote within the United StatesFull-TimeManager
Salary$165,000–$180,000 USD
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Job Details
- Experience
- At least 6 years of experience in pharmaceutical drug development
- Required Skills
- GCP
Requirements
- Bachelor’s degree in biological sciences, life sciences, or related field.
- At least 6 years of experience in pharmaceutical drug development with a focus on CQA and/or GCP-related functions.
- Expertise in interpreting ICH guidelines and domestic/international GCP regulations.
- Proven experience leading GCP, GCLP, and GPvP audits of investigator sites and clinical vendors.
- Experience managing inspection readiness and supporting FDA/EMA health authority inspections.
- Strong understanding of quality systems, audit lifecycle, deviations, and CAPA management.
- Excellent communication and relationship-building skills to collaborate with diverse stakeholders.
- Proficiency with electronic quality management systems (preferably Veeva Quality Vault).
- Quality Auditor or Quality Manager certification is preferred.
Responsibilities
- Provide GCP compliance oversight and quality guidance to clinical study teams by participating in meetings and reviewing documentation.
- Identify, assess, and escalate serious compliance issues or potential breaches to leadership.
- Lead or support internal and external GCP audits, including planning, execution, and CAPA management.
- Conduct audits of investigator sites, clinical vendors, and internal clinical functions.
- Manage study deviations, quality events, and CAPAs within the GCP and pharmacovigilance areas.
- Support partner audits, regulatory inspections, and inspection readiness initiatives with health authorities like the FDA and EMA.
- Contribute to strategic quality and compliance process improvement initiatives.
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