Manages, implements and coordinates quality assurance program to prevent or minimize risk to the integrity of data across all manufacturing sites. The Director, Data Integrity Assurance and Compliance provides independent oversight to the data integrity program for all manufacturing and R&D sites including data generation and review. This individual will work in a detail oriented, compliant manner to ensure the operations align with Akorn policies and procedures as well as cGMPs and industry data integrity expectations. This position reports directly to the SVP, Corporate Quality.
- Directs overall coordination, collection, evaluation, and compliance of data across all manufacturing sites to meet compliance requirements
- Develop and maintain Data Integrity System for all sites, including ownership of Data Integrity SOPs and policies, to ensure compliance with regulations
- Provides strategic input to Quality Assurance department related to data integrity
- Oversees audits of laboratory and manufacturing data
- Oversees investigations of significant data integrity issues
- Provides oversight to the Commercial and ANDA stability programs
- Provides oversight and support of GMP-IT Systems (Computerized data systems)
- Conduct routine Data Integrity related training
- Bachelorâ€™s Degree (BS or BA) in a science related filed (i.e. math, chemistry, biology)
- 10+ years demonstrated excellence in a managerial or supervisor role in the pharmaceutical industry
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.