Senior Director, Quality Assurance

🔥 7 minutes ago

🇺🇸 United States – Remote

💵 $225k - $275k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Elevar Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $20M Venture Round - Elevar Therapeutics on 2018-07

Biotechnology • Pharmaceuticals • Healthcare

Elevar Therapeutics is a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. With a foundation rooted in oncology, the company is dedicated to identifying and developing promising medicines for complex and under-treated health conditions across a range of therapeutic areas. Elevar Therapeutics takes a relentless and inventive approach towards advancing next-generation therapies that aim to set new standards of care and improve patient experiences, all while maintaining the highest ethical standards.

📋 Description

• 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

🎯 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 • Experience conducting supplier audits and internal audits • Ability to demonstrate 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