Director, Clinical – Nonclinical Quality Assurance
Location
United States
Posted
15 hours ago
Salary
$150K - $240K / year
Seniority
Lead
Job Description
Job Requirements
- Bachelor’s degree in Biological, Life Sciences or relevant discipline.
- 12+ years of experience in pharmaceutical drug development in Clinical & Non-Clinical Quality Assurance
- Strong knowledge of relevant GLP/GCP FDA and ICH guidelines and regulations.
- Demonstrated success as a primary or sole QA lead supporting early- late phase clinical and nonclinical programs.
- Ability to interpret regulatory rules, guidance, and normative industry standards.
- Hands-on leadership of audits and inspection readiness with successful outcomes.
- Oversight of multiple product programs across the drug development lifecycle.
- Experience in GLP/GCP inspection preparation and management
- Knowledge of the US regulatory drugs and/or biologics approval process.
- Experience with Quality system applications (e.g., eDMS, QMS - Veeva)
- Proficiency in budget forecast and planning
Benefits
- Medical, Dental & Vision Insurance
- Basic and Voluntary Life and AD&D Insurance
- Short- and Long-Term Disability Insurance
- Flexible Spending Accounts
- Health Savings Account
- Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off
- Sick Time
- Paid Holidays
- Career Development and Training
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