Executive Director, Quality Assurance, GMP

Role Summary

Responsibilities

• Responsible for all quality-related matters related to manufacturing, testing and release at a CMO (Contract Manufacturing Organization); act as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and controls.
• Lead and support activities related to external quality such as, but not limited to, batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications including auditing and monitoring.
• Collaborate with internal CMC functions and aligns goals and objectives from clinical to commercial phase programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
• Ensure quality policies and objectives are understood, implemented, and maintained for all applicable GMP roles. Identifies gaps and provides solutions for new processes and documents to ensure readiness for inspections and audits.
• Author and review or approve quality documents including quality agreements, certificates of release, and audit reports.
• Attend CMO and internal CMC team meetings and provide quality feedback supporting Xenon products including collaborations on complex investigations.
• Attend and support quality system and product review meetings including providing data for quality metrics (internal and vendor metrics). Provide quality reviews of key CMC and health authority documents. Review and verify data to assure compliance with data integrity.
• Represent Quality function on project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings.
• Promote a quality mindset and quality excellence approach throughout the organization.
• Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
• Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in a life sciences discipline, with 12+ years of experience in GMP quality leadership positions.
• Strong understanding of small molecule manufacturing with direct experience in solid oral dosage.
• Experience with a small virtual company; Quality Control experience is a plus.
• Strong knowledge of global GxP expectations, QP (Qualified Person) requirements including work with health authorities.
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
• Extensive experience establishing key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
• Strong interpersonal skills, with experience in leading high-performance team and cross functional projects including a successful track record working with suppliers and CMOs.
• Extensive GxP knowledge with early phase drug development through commercialization.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CMOs.
• Goal oriented with the ability to troubleshoot and resolve problems.
• Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes and appropriately structured quality operations.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Team building and managing skills including recruiting, coaching, counseling, and disciplining.

Skills

• GxP knowledge; GMP quality leadership; QA for manufacturing, testing, and release; cGMP compliance; data integrity; quality systems; vendor and supplier management; CMO collaboration; health authority interactions; risk-based inspection readiness.

Education

• Bachelor’s degree in a life sciences discipline

Additional Requirements

• Some international travel may be required.