Executive Director, Quality Assurance

What you'll do:

• Provides overall leadership for the QA function to establish compliant processes and systems that support collaboration.
• Ensures personnel, processes, documentation and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
• Identifies and assesses development quality risks and ensures they are evaluated and managed appropriately to accomplish regulatory and quality requirements.
• Formulates quality and compliance policies in coordination with corporate management and ensures that all required systems and standard operating procedures are in place and current.
• Ensures monitoring and auditing of development operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions.
• Fosters an environment of collaboration, trust, quality, innovation, and continuous improvement within the QA organization and with other functional departments.
• Develops and maintains effective working relationships within the organization.
• Identifies emerging trends/changes and redesigns processes and practices accordingly.
• Establishes, implements, and maintains performance metrics.
• Responsible for providing regular performance feedback, development, and coaching to direct reports.
• Develops and approves QA budgets and schedules to meet corporate requirements.
• Develops a robust quality system and fosters best practices across the organization.
• Other responsibilities assigned as needed.

About you:

• BS or BA in Scientific Field; MS or Ph.D. in Scientific Field preferred
• A minimum of a Bachelor’s degree in a scientific discipline is required; an advanced degree is preferred. Equivalent experience may be accepted.
• A minimum of 15+ years of experience in the pharmaceutical or other related industry with at least 10 years of management experience.
• A minimum of 15 years working experience in a Quality environment with expert knowledge of compliance audits.
• Experience developing and managing late-stage clinical and commercial Quality Assurance organizations.
• Experience and oversight across clinical and commercial product divisions.
• Experience working in the fields of gene therapy, cell therapy, or another emerging therapeutic technology is highly desired.
• Comprehensive knowledge of GCP, GLP, GMP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development and commercialization.
• Demonstrated ability to provide leadership for significant quality policies, practices, and processes with respect to quality compliance.
• Experience with process improvement techniques and practices.
• Experience preparing for and successfully managing regulatory inspections.
• Demonstrated ability to anticipate and proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards).
• A self-starter with considerable managerial/leadership experience and a demonstrated ability to interact with various levels of management to accomplish goals and objectives.
• High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.
• Ability to partner with a diverse group of staff/consultants with different strengths and skills and ability to prioritize work, manage multiple projects, while maintaining quality. 

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