Senior Director, Quality Assurance

Posted 1hrs ago

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Senior Director overseeing QA systems, GMP compliance, audits, and quality improvement for Elevar Therapeutics’ drug manufacturing operations.

Oversee the Quality Assurance department and ensure departmental strategic plans and objectives are met
Ensure drug manufacturing and release processes comply with government regulations and GMP standards
Develop, implement, maintain, and improve the corporate quality assurance system
Provide oversight of all cGMP activities
Champion continuous improvement to establish an effective Quality Management System (QMS)
Support and guide compliance with regulatory requirements
Oversee commercial products and maintain Elevar’s compliance objectives
Establish and enforce quality standards and regulatory requirements
Direct quality assurance staff through recruiting, selecting, orienting, and training
Encourage employee engagement and results through delegation, feedback, goal setting, and performance reviews
Ensure the QMS reflects Elevar’s changing roles and responsibilities in drug manufacturing and research
Initiate and implement quality improvement activities
Write and update quality assurance procedures
Ensure employees receive required GMP training and education
Interact with suppliers to identify quality improvements and monitor performance
Interface with supplier quality representatives to address quality control problems and implement corrective action

Bachelor’s or Master’s degree in science, engineering, or business discipline with 15+ years' experience
10 years' experience in a QA systems leadership position and implementation
Firsthand experience of audits by regulatory authorities
Working knowledge of quality system requirements
Demonstrated track record and success in team building skills and people management and leadership
Track record of business performance improvement
Experience hosting FDA and other regulatory authority audits
Experience conducting supplier audits and internal audits
Ability to demonstrate Elevar’s core values, including accountability, effective remote collaboration, ingenuity, and compassion