Dir, Quality Assurance Operations

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

Join to apply for the Dir, Quality Assurance role at Alkermes

Management of Quality Assurance functions across the Wilmington, Ohio site. Ensure compliance with FDA, EU, and other regulations, and maintain inspection readiness. Interface with regulatory agencies, customers, consultants, and corporate functions.

Major Responsibilities:

• Decision-making on quality assurance matters, policy and standard improvements (25%)
• Staffing, training, and personnel development (25%)
• Oversight of batch review, manufacturing activities, product release, and clinical release (25%)
• Management of quality systems including deviations, investigations, complaints, audits, data integrity, and compliance (25%)

Qualifications:

• Team-oriented, detail-focused, organized, innovative, adaptable, capable of managing multiple tasks
• Strong communication skills
• Leadership with influence, coaching, and collaboration skills
• Experience in FDA-regulated pharmaceutical manufacturing
• Knowledge of regulatory compliance, process validation, technology transfer, and software skills
• Ability to analyze complex technical issues and make compliant decisions
• Expertise in pharmaceutical quality operations, parenteral and oral dosage experience preferred
• Experience in CGMP compliance for clinical to commercial products

Education & Experience:

• Bachelor of Science degree
• 15+ years in pharmaceutical industry with progressive quality leadership
• At least 5 years in managerial quality roles

Work Conditions: On-site, flexible hours, occasional travel. No special physical requirements.

About Alkermes: A biopharmaceutical company dedicated to neuroscience, with a focus on psychiatric and neurological disorders. Committed to diversity, inclusion, and making a positive impact on patients’ lives. Recognized as a Great Place to Work and other awards.

Seniority level: Director

Employment type: Full-time

Job function: Quality Assurance