The Senior Director, Quality Assurance oversees the Quality Assurance department and ensures the strategic plans and objectives of the department are met. The QA department is responsible for ensuring that the drug manufacturing and release processes comply with all applicable government regulations and GMP standards. This position is responsible for developing, implementing, maintaining, and improving the corporate quality assurance system and has oversight to all cGMP activities. The Senior Director, Quality Assurance champions continuous improvement efforts to establish an effective Quality Management System (QMS) and provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements.
This is a remote-based position located in the United States.Responsibilities:- Responsible for oversight of Elevar's commercial products and ensuring Elevar's compliance objectives are maintained and updated to meet overall organizational needs
- Assure quality products and processes by establishing and enforcing quality standards and regulatory requirements
- Directs the activities of the quality assurance staff by recruiting, selecting, orienting, and training employees
- Encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance reviews
- Ensures that the QMS is reflective and appropriate for Elevar's changing and expanding roles and responsibilities as a drug manufacturer and in non-clinical and clinical research
- Initiates and implements quality improvement activities as appropriate to raise the performance of the company
- Writes and updates quality assurance procedures
- Ensures that employees receive required GMP training and education
- Interacts with suppliers to identify opportunities to improve quality and monitor performance
- Interfaces with supplier quality representatives concerning problems with quality control and assure that effective corrective action is implemented
Requirements
- 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 and conducting supplier audits and internal audits
- Ability to demonstrate Elevar's core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
The anticipated annual base salary range for this role is $225,000 to $275,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.
#LI-REMOTE
