Director, Quality Assurance Ops – On-site & Flexible

Alkermes; Cincinnati (OH); On-site; USD 150,000 - 200,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Quality Assurance to manage critical quality functions at their Wilmington, Ohio site. This role requires extensive experience in FDA-regulated manufacturing, strong leadership, and the ability to ensure compliance with various regulations. You will be responsible for overseeing quality systems, personnel development, and interfacing with regulatory agencies. The company values diversity and aims to make a positive impact on patients’ lives.

Qualifications

• 15+ years in the pharmaceutical industry with progressive quality leadership.
• At least 5 years in managerial quality roles.

Responsibilities

• Decision-making on quality assurance matters.
• Staffing, training, and personnel development.
• Oversight of batch review, manufacturing activities, product release.

Skills

Team-oriented

Detail-focused

Strong communication skills

Leadership with influence

Ability to analyze complex issues

Education

Bachelor of Science degree

Job description

A leading biopharmaceutical company is seeking a Director of Quality Assurance to manage critical quality functions at their Wilmington, Ohio site. This role requires extensive experience in FDA-regulated manufacturing, strong leadership, and the ability to ensure compliance with various regulations. You will be responsible for overseeing quality systems, personnel development, and interfacing with regulatory agencies. The company values diversity and aims to make a positive impact on patients’ lives.