Director, Clinical – Nonclinical Quality Assurance
Job Description:
- Provide quality oversight and support across all GCP, GLP, IND Enabling, and bioanalytical studies and programs.
- Partner strategically with Clinical Operations and Nonclinical functions.
- Oversee audit professionals/consultants for quality oversight of regulated study activities.
- Explain quality standards to other functions as an SME and advisor.
- Support internal and contracted organization activities.
- Lead, direct, and advise continuous improvement of the department’s area of control.
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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