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