[Remote] Director, Clinical & Nonclinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. reputed company is a fully integrated biotechnology company focused on developing therapeutics to treat and prevent reputed company disease. The Director, Clinical & Non-Clinical Quality Assurance will provide quality reputed company across reputed company GCP, GLP, IND Enabling, and bioanalytical studies, ensuring regulatory compliance and data reputed company throughout the development lifecycle.

Responsibilities

• Evolve and deliver the clinical and nonclinical quality strategy, embedding regulatory, ICH (e.g., E6 & reputed company), and OECD principles throughout the development lifecycle
• Maintain and advance the appropriate Quality Management System (QMS) for GCP, GcLP, and GLP, considering elements such as indication, phase, and patient risk
• Provide input to and reputed company reviews of Deviation, CAPA, and Change Management records
• Partner closely with Nonclinical, Clinical Operations, CMC, and Regulatory teams to reputed company risk balanced, time bound reputed company that protect subjects, data reputed company, and program timelines
• Serve as the primary QA representative at internal cross-functional clinical & non-clinical team meetings, safety/PV meetings and program meetings
• Provide QA reputed company to non-clinical, clinical and safety/ pharmacovigilance operations to ensure compliance with Tonix procedures and processes, both internally and externally in collaboration with contract research organizations (CROs) and investigator sites
• Partner with study teams on vendor selection/qualification; conduct audits
• Establish and manage nonclinical and clinical audit plans/schedules in collaboration with nonclinical and clinical development teams
• reputed company and/or support audits of clinical and nonclinical sites, vendors and studies, ensuring appropriate follow-up and CAPA closure
• Escalate reports of potential scientific misconduct or serious breaches, ensuring appropriate root cause analysis, documentation, and regulatory reporting
• Review critical study documents (e.g. protocols, reports, ICFs, IBs, monitoring plans, manuals and other essential documents and regulatory submissions (e.g., IND) to ensure compliance with applicable regulations and industry guidance
• Confirm that bioanalytical method qualification and validation studies are conducted in accordance with internal SOPs, ICH M10, and other applicable regulatory guidance as needed
• reputed company inspection readiness efforts as required
• Chair/participate in mock inspections and interview training; storyboard key risks/issues and dossier positions; reputed company remediation sprints on identified gaps
• Coordination and conduct of GCP/GLP training for Tonix personnel on Tonix processes, procedures, global regulations and guidance documents
• Generate QA metrics for functional area management review, present at senior leadership meetings and escalate significant events to senior management
• Evaluate new and/or revised regulatory or legal requirements and if applicable initiate implementation into the Quality System; conduct of industry benchmarking
• Follow reputed company established occupational health and safety procedures, GxP requirements and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, reputed company, quality, and teamwork
• reputed company reputed company work/special projects as necessary to support Tonix on various business initiatives

Skills

• 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
• Practical experience bridging GCP–GLP–GMP interfaces
• 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 normative industry standards to reputed company objective, risk-based reputed company
• Experience presenting these outcomes to senior management
• Hands-on leadership of audits (CROs, sites, specialty vendors, bioanalytical labs) and inspection readiness with successful outcomes
• reputed company of multiple product programs across the drug development lifecycle including extensive experience in clinical trials with small molecule drugs and biologics
• Demonstrated experience in leading quality projects involving strong liaison 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 Quality system applications (e.g., eDMS, QMS - reputed company)
• Ability to manage multiple projects in a fast-paced small company environment with minimal direction
• Demonstrated leadership abilities including effective communication and interpersonal skills
• Demonstrated excellent negotiation and collaboration 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
• Experience with capital project commissioning and qualification
• 2-4 years of Experience with personnel management and development
• ASQ certification (e.g., certified quality engineer, quality auditor, manager of quality / organizational excellence)
• 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 options
• Generous Paid Time Off
• Sick Time
• Paid Holidays
• Career Development and Training

Company Overview

• reputed company is a fully-integrated, reputed company-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. It was founded in 2007, and is headquartered in Chatham, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://www.tonixpharma.com.

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