Senior QA Manager, Quality Systems
Akorn 2

The Senior Manager of Quality Systems manages, implements, and coordinates our investigation / CAPA program, document control, training, release and annual product reviews, quality management reviews, and change control process.

• Final review and Quality evaluation of non-conformances, deviations and quality events related to deviations from standard operating procedures, sterility test failures, out of specification and out of trend results.
• Provides final risk-based evaluation and disposition of product following review of completed investigations.
• Reviews and approve CAPA plans and effectiveness checks.
• Reviews and evaluate investigations of product complaints.
• Member of the site team for both internal and external audits and responses
• Provides guidance to the document control team.
• Manages the site quality management reviews.
• Manages change control process for the site.
• Provides feedback to investigators to ensure all investigations are thorough with appropriate root cause analysis.
• Directly responsible for performance reviews, goal setting and personnel development plans for Quality System team.

• Assists in recruiting, interviewing and hiring qualified employees to fill open positions.
• Planning, assigning and directing work.
• Addressing complaints and resolving personnel problems within the department.
• Maintaining confidentiality of information.
• Evaluates and incorporates training programs to enhance root cause training and investigation writing for management and supervisory personnel.

Qualifications

• Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's.
• Minimum of bachelor's degree in a science related filed (i.e., math, chemistry, biology) and a minimum of 10 years related experience in the pharmaceutical environment, with sufficient training and knowledge to perform all required.
• Minimum of 5 years demonstrated excellence in a managerial role in the pharmaceutical industry.

Company Overview
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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