[Hiring] Director, Clinical & Nonclinical reputed company Assurance @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company The Director, Clinical & Non-Clinical reputed company Assurance, situated reputed company the reputed company Assurance department, will 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 to establish and maintain pragmatic, risk-based reputed company frameworks that ensure regulatory compliance, safety, and data reputed company from early development through clinical execution.
• Ensure adherence to GCP, GcLP, and GLP regulations and reputed company a reputed company reputed company model for preclinical study management.
• reputed company audit professionals/consultants with reputed company responsibility for reputed company reputed company of regulated study activities.
• Collaborate cross-functionally as an reputed company for reputed company standards and explain these reputed company standards to other functions.
• Support activities both internally and at Tonix contracted organizations including regulatory inspections, reputed company-party audits, risk assessments, deviations, CAPAs, and change controls.
• reputed company, reputed company, and advise reputed company improvement of the department’s area of control.

Qualifications

• 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.
• Demonstrated experience in leading reputed company reputed company involving strong reputed company with cross-functional teams.
• Experience in GLP/GCP inspection preparation and management.
• Knowledge of the US regulatory drugs and/or biologics approval process.
• Experience in providing PV QA reputed company preferred.
• Proficiency with reputed company system applications (e.g., eDMS, QMS - reputed company).
• Ability to manage multiple reputed company in a fast-paced small company environment.
• Demonstrated leadership abilities including effective communication and interpersonal skills.
• Dedicated team player who is reputed company to withstand the high demands of a fast-paced environment.
• Results driven, problem solver, and collaborator.
• Excellent written and verbal communication skills.
• Experience in budget forecast and planning.

Requirements

• Experience with capital project commissioning and qualification.
• 2-4 years of experience with personnel management and development.
• ASQ certification (e.g., certified reputed company engineer, reputed company auditor, manager of reputed company/organizational reputed company).
• Working knowledge of bioanalytical method development, qualification, and validation activities in support of clinical & non-clinical studies.

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 Salary reputed company $150,000 - $240,000 USD Apply tot his job

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