Senior Director, Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the Quality Assurance division and ensure the strategic plans and objectives of the department are achieved

• Guarantee that drug manufacturing and release processes adhere to government regulations and GMP standards

• Create, implement, maintain, and enhance the corporate quality assurance system

• Provide oversight for all cGMP activities

• Advocate for continuous improvement to establish a robust Quality Management System (QMS)

• Assist and guide adherence to regulatory requirements

• Oversee commercial products and uphold Elevar’s compliance goals

• Set and enforce quality standards and regulatory requirements

• Manage quality assurance personnel through recruitment, selection, orientation, and training

• Foster employee engagement and outcomes through delegation, feedback, goal setting, and performance evaluations

• Ensure the QMS adapts to Elevar’s evolving roles and responsibilities in drug manufacturing and research

• Initiate and execute quality improvement initiatives

• Draft and revise quality assurance procedures

• Ensure that employees receive the necessary GMP training and education

• Collaborate with suppliers to identify quality enhancements and monitor their performance

• Liaise with supplier quality representatives to resolve quality control issues and implement corrective measures

⛳️ Requirements

• Bachelor’s or Master’s degree in a scientific, engineering, or business field with over 15 years of experience

• At least 10 years of experience in a QA systems leadership role and implementation

• Direct experience with audits conducted by regulatory authorities

• Proficient understanding of quality system requirements

• Proven success in team building, people management, and leadership skills

• History of enhancing business performance

• Experience facilitating FDA and other regulatory authority audits

• Background in conducting supplier audits and internal audits

• Ability to exemplify Elevar’s core values, including accountability, effective remote collaboration, ingenuity, and compassion

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Time off

• Retirement plan

• Other voluntary benefits

• Competitive wages