Director Quality Assurance
Job Description
Job Description
Quality Assurance Manager/Director
Company: Applied Biologics
Location: Scottsdale, Arizona (Onsite)
Department: Quality Assurance & Control
Employment Type: Full-Time
About Us
Applied Biologics is a leading biopharma company pioneering regenerative medicine and biologics for therapeutic applications. We are committed to innovation, compliance, and ensuring the highest standards in product quality and safety.
Role Overview
We are seeking a Quality Assurance Manager with proven leadership in biopharma or pharma to oversee laboratory operations, testing, and regulatory compliance. This is a full-time onsite role in Scottsdale, AZ, offering a competitive salary and comprehensive benefits package.
Key Responsibilities
- Lead and manage the QA team, ensuring adherence to testing protocols and regulatory guidelines.
- Oversee release testing of raw materials, intermediates, and finished products.
- Implement and maintain quality systems, including SOPs, deviation management, and CAPA.
- Collaborate with R&D, manufacturing, and QA teams to support product development and commercial production.
- Ensure compliance with GMP, GLP, FDA, and EMA standards.
- Prepare and present QC reports to senior leadership and regulatory agencies as required.
- Train and mentor junior QA staff in best practices and compliance standards.
Qualifications
- Proven management experience in biopharma or pharma quality control.
- Strong knowledge of analytical methods, microbiological testing, and process validation.
- Familiarity with FDA/EMA regulations, ICH guidelines, and global quality standards.
- Excellent leadership, communication, and problem-solving skills.
Compensation & Benefits
- Competitive salary (based on experience)
- 401(k) plan
- Health insurance
- Dental insurance
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