Senior Director, Clinical Quality Assurance (CQA)
New
4
4DMTBiotechnology
Remote, United StatesFull-TimeDirector
Salary245,000 - 286,000 USD per year
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Job Details
- Experience
- 12+ years of experience or advanced degree with 10+ years of experience
- Required Skills
- GCPRisk Management
Requirements
- Bachelor's degree in a life science, nursing, pharmacy, or related field (Advanced degree preferred).
- 12+ years of experience or advanced degree with 10+ years of experience in regulated environments like Regulatory, Quality, Pharmacovigilance, or Clinical Development.
- Minimum of 7 years of specific experience in clinical quality assurance.
- Expert understanding of GCP requirements for investigational products.
- Proven experience leading Clinical quality strategy and quality governance for global clinical trials.
- Significant experience leading or performing GCP audits of clinical trials and vendors.
- Extensive experience hosting and managing health authority inspections.
- Demonstrated ability to influence senior cross-functional stakeholders.
- Strong leadership, interpersonal, and communication skills.
- Ability to operate independently in a fast-paced environment.
Responsibilities
- Provide strategic Quality leadership and oversight for multiple 4DMT Clinical Studies.
- Serve as a senior Quality partner to clinical study teams, providing guidance on GCP, ICH E6, and related regulations.
- Develop, implement, and govern Clinical Study Quality Plans to protect subject safety and data integrity.
- Manage, mentor, and develop Clinical QA staff and consultants.
- Plan and oversee risk-based GCP Compliance audits of clinical vendors and investigator sites.
- Communicate audit findings and CAPA commitments to senior stakeholders and track resolution.
- Lead the investigation and management of significant Clinical Study Quality Events.
- Define and lead GCP inspection readiness strategy, including mock inspections and logistics.
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