Director, Quality Assurance Operations

Tonix Pharmaceuticals•Berkeley Heights, NJ

4d•$180,000 - $220,000

About The Position

The Director of Quality Assurance Operations provides strategic leadership and oversight for Quality Assurance activities supporting commercial and clinical manufacturing, distribution, and supply chain operations. As a senior member of the Quality leadership team, the Director partners with management to develop and execute quality operations and compliance strategies that support corporate objectives, regulatory requirements, and business growth. The Director is accountable for the effectiveness of Quality Operations programs, directs departmental activities through staff, and serves as the final Quality decision-maker for assigned operational quality matters. The role is accountable for departmental budget management, resource planning, organizational effectiveness, and quality compliance outcomes across internal operations and external business partners.

Requirements

B.S. degree, preferably in a scientific discipline.
Ten years of pharmaceutical or biopharmaceutical industry experience; seven years of Quality Assurance experience in U.S./EU environments preferred.
Seven years of direct supervisory experience with increasing responsibility preferred.
Strong knowledge of U.S. FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application.
Direct experience managing Quality System activities in regulated pharmaceutical or biotechnology environments.
Knowledge of the drug development and commercialization process.
Proficiency with quality system applications such as eDMS and QMS.
Experience with commercial GxP processes, including Good Distribution Practices and the Drug Supply Chain Security Act (DSCSA).
Comprehension of appropriate escalation regarding Quality and product or patient safety issues.
Excellent written and verbal communication skills.
Strong planning and organizational skills.
Team-oriented and able to withstand the high demands of a fast-paced environment.
Comfort working independently with minimal supervision.
Results-driven, with problem-solving and collaboration abilities.
Demonstrated ability to perform the essential duties of the position with or without accommodation.
Ability to travel up to 20% of the time.

Nice To Haves

Veeva Vault experience.
Experience participating in or hosting regulatory inspections and interacting with regulators.
Seven years of direct supervisory experience with increasing responsibility.
Seven years of Quality Assurance experience in U.S./EU environments.

Responsibilities

Develop and execute the Quality Operations strategy with senior leadership to support commercial and development programs.
Participate with senior management in establishing long-term quality, compliance, inspection-readiness, and operational objectives.
Direct quality operations across multiple functional areas and remain accountable for departmental performance and strategic objectives.
Establish department goals, performance metrics, and resource plans aligned with organizational priorities and business objectives.
Identify, evaluate, and communicate product quality and compliance risks; drive mitigation strategies and make final decisions on quality risk assessments, remediation plans, and escalations for assigned operational matters.
Lead and develop a multi-level Quality organization, including hiring, performance management, compensation recommendations, promotions, succession planning, disciplinary actions, and terminations.
Approve staffing plans and workforce allocations, allocate resources, and provide strategic leadership for organization design and resource planning.
Build relationships with contract Quality organizations to ensure timely resolution of quality issues.
Partner with internal project teams to ensure QMS adherence and promote best practices in quality record generation and closure.
Direct lot disposition for commercial and clinical supply and approve product disposition decisions and quality-related supply chain actions.
Support development and review of Annual Product Reviews, contributing quality content and advising on improvements based on trends, findings, and risks.
Oversee GDP and DSCSA compliance to support compliant distribution, product traceability, and supply chain security.
Oversee artwork management to ensure compliant control, approval, and implementation of labeling and packaging materials.
Manage third-party audits and participate in internal audits and regulatory inspections.
Review regulatory submission documentation related to NDAs, BLAs, INDs, information requests, and annual reports.
Analyze, report, and present metrics to functional teams and Quality management; identify risks, recommend actions, and monitor implementation of mitigation or preventive actions.
Author, review, and/or approve internal policies, procedures, and quality documentation.
Manage the Quality Operations budget, approve expenditures and resource allocations, monitor financial performance, implement corrective actions, and provide forecasts and investment recommendations to senior leadership.