10 years in Pharmaceutical/Biopharmaceutical industry, with 7 years in Quality Assurance
7 years of supervisory experience with increasing responsibility
Experience with electronic Quality systems (e.g., eDMS, QMS); Veeva Vault preferred
Familiarity with regulatory inspections and interactions with regulators
Knowledge of commercial GxP processes and DSCSA compliance
Strong understanding of US-FDA, ISO, ICH, and GxP principles
Responsibilities
Develop and execute Quality Operations strategy with senior leadership
Establish long-term quality and compliance objectives
Direct quality operations across multiple functional areas
Set departmental goals and performance metrics
Identify and mitigate product quality and compliance risks
Lead and develop Quality Assurance Operations personnel
Manage departmental budget and resource allocation
Benefits
Medical, Dental & Vision Insurance
Life and AD&D Insurance, Short- and Long-Term Disability Insurance
Flexible Spending Accounts and Health Savings Account
Pet Insurance
401k with company match and stock options
Generous Paid Time Off and Sick Time
Career Development and Training opportunities
Full Job Description
Position Overview
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, this role partners with management to develop and execute quality operations and compliance strategies that support corporate objectives, regulatory requirements, and business growth.
The Director maintains accountability 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 position is accountable for departmental budget management, resource planning, organizational effectiveness, and quality compliance outcomes across internal operations and external business partners.
Key Responsibilities
Develop and execute the Quality Operations strategy in partnership 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 activities across multiple functional areas. Accountable for overall departmental performance and achievement of 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 and drive mitigation strategies. Serve as the final Quality authority for operational quality decisions impacting assigned products, processes and compliance programs. Make final decisions regarding quality risk assessments, compliance remediation plans and escalation actions.
Lead a multi-level Quality organization and develop Quality Assurance Operations personnel. Exercise authority for hiring, performance management, compensation recommendations, promotions, succession planning, disciplinary actions, and terminations.
Approve staffing plans and workforce allocations. Allocate departmental resources to achieve business and compliance objectives. Provide strategic leadership for departmental organization design and resource planning.
Establish strong relationships with contract Quality organizations to ensure timely resolution of quality issues
Partner with the internal project teams to ensure adherence to Quality Management System (QMS) requirements and drive best practices in quality record generation and closure
Direct lot disposition activities in support of commercial and clinical supply demands. Serve as the Quality approver for product disposition decisions and quality-related supply chain actions.
Support the development, and review of Annual Product Reviews (APRs), contributing quality-related content and advising on improvements based on identified trends, findings, and risks.
Oversee GDP and DSCSA compliance activities to ensure compliant distribution, product traceability, and supply chain security
Oversee artwork management processes to ensure compliant control, approval, and implementation of labeling and packaging materials
Manage third-party audits and participate in internal audits as well as 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 any risks and recommend any required actions and monitor implementation of mitigation or preventive actions
Author, review, and/or approve internal policies, procedures and quality documentation
Develop, manage and maintain accountability for the Quality Operations budget. Approve departmental expenditures and resource allocations. Monitor financial performance and implement corrective actions to achieve budget objectives. Provide budget forecasts and investment recommendations to senior leadership.
Qualifications
B.S. degree preferably in a scientific discipline
Ten (10) years of Pharmaceutical/Biopharmaceutical industry experience with seven (7) years of Quality Assurance experience in US/EU environments preferred
Seven (7) years of direct supervisory experience with increasing responsibility over time preferred
Experience participating in/hosting regulatory inspections and interacting with regulators preferred
Experience with commercial GxP processes including Good Distribution Practices and Drug Supply Chain Security Act (DSCSA)
Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application
Direct experience managing Quality System activities within regulated pharmaceutical or biotechnology environments
Knowledge of the drug development and commercialization process
Proficiency with Quality system applications (e.g.,eDMS, QMS)
Comprehension of appropriate escalation regarding Quality as well as product and/or patient safety issues
Excellent written and verbal communication skills
Strong planning and organizational skills
Dedicated team player who can withstand the high demands of a fast-paced environment
Comfortable working independently with minimal supervision
Results driven, problem solver, and collaborator
Demonstrated ability to perform the essential duties of the position with or without accommodation
Ability for travel up to 20% of the time
Salary Range
$180,000-$220,000 USD
*Please note that Tonix does not offer sponsorship for this role.
Recruitment & Staffing Agencies
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & Benefits
Tonix provides a comprehensive compensation and benefits package which includes:
Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
Pet Insurance
Retirement Savings 401k with company match and annual discretionary stock options
Generous Paid Time Off, Sick Time, & Paid Holidays
