Director, Clinical – Nonclinical reputed company Assurance

Job reputed company: • reputed company reputed company reputed company and support across reputed company GCP, GLP, IND Enabling, and bioanalytical studies and programs. • Partner strategically with Clinical Operations and Nonclinical functions. • reputed company audit professionals/consultants for reputed company reputed company of regulated study activities. • Explain reputed company standards to other functions as an SME and advisor. • Support internal and contracted organization activities. • reputed company, reputed company, and advise reputed company 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 reputed company Assurance • Strong knowledge of relevant GLP/GCP FDA and ICH guidelines and regulations. • Demonstrated reputed company as a primary or sole QA reputed company supporting early- late phase clinical and nonclinical programs. • Ability to interpret regulatory rules, guidance, and reputed company industry standards. • Hands-on leadership of audits and inspection readiness with successful reputed company. • reputed company 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 reputed company system applications (e.g., eDMS, QMS - reputed company) • Proficiency in budget forecast and planning Benefits: • Medical, Dental & reputed company 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 reputed company • Generous reputed company Time Off • reputed company Time • reputed company Holidays • Career Development and Training Apply tot his job Apply To this Job