Associate Director, Quality Systems & Compliance
Akorn 2

Somerset, New Jersey

Posted in Pharmaceuticals


This job has expired.

Job Info


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  • Develop, implement, sustain, and improve Quality Systems Program to ensure all FDA, other regulatory authority and internal audit commitments as well as commitment arising from any Akorn Quality Improvement initiatives.
  • Ensure files are maintained to demonstrate completion of commitments with adequate supporting documentation.
  • Interact with site personnel at all levels to ensure timely completion of FDA, other regulatory authority and internal audit commitments as well as commitment arising from any Akorn Quality Improvement initiatives.
  • Interact with counterparts at other Akorn sites and corporate functions to harmonize approach for closure of commitments.
  • Ensure site representation on Akorn Quality Improvement initiatives.
  • Support site audits as required.
  • Support, as necessary, product release and cross-train with quality systems counterpart.
  • Administer the site quality assurance program as delegated by the Executive Director - Site Quality.
  • Act as a delegate/assigned designee to perform functions on behalf of the Executive Director, Quality as it relates to Quality Assurance production support and documentation.
  • Responsible for the overall direction, coordination and evaluation of this unit. Directly supervises Managers for QA Production Support and Documentation.


  • Qualifications
    • Bachelor’s Degree in a science related field (i.e. math, chemistry, biology) required.
    • A minimum of 10 years’ experience in the pharmaceutical industry with ten years related managerial or supervisor experience preferred.
    • Excellent interpersonal, oral, and written communication skills.
    • Requires exceptional attention to detail with the ability to focus on current assignments.
    • Must have accomplished skills in computer-assisted documentation systems.
    • Must have GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.


    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.


    This job has expired.

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