Vice President - Corporate Quality Compliance - Akorn - Lake Forest

Job description
Our Company
We are a rapidly growing pharmaceutical manufacturer with strong lines in hospital and ophthalmic markets, and many new products in development and awaiting FDA approval. In anticipation of long-term, substantial growth, we offer challenging, attractive career opportunities along with competitive salaries and comprehensive benefits. Akorn is an Equal Opportunity Employer. M/F/V/D.
Summary
The purpose of this position is to manage internal compliance programming and Akorn’s DEA program. Primary focus is ensuring understanding of and compliance with applicable regulatory requirements and standards (e.g. cGMP’s, ISO, DEA, etc.)
Essential Functions
Maintain and optimize Akorn’s supplier quality assurance program to assure that this global program remains in compliance with applicable regulatory / industry regulations and standards.
Develop, deploy, maintain and provide Quality oversight for the Akorn Quality System Policy (QSP) program, and its alignment with applicable industry and regulatory agency standards, regulations and laws.
Provide quality related evaluation and support for all Akorn analytical method development, validation and verification activities - for new and existing products and processes.
Monitor and integrate prevailing external regulatory and standards criteria into Akorn Quality System programming, and assure compliance with such criteria.
Oversee the implementation and compliance of external quality certification programs i.e. STR-R, ISO `3485 at Akorn sites.
Maintain current local, state, federal and/or international licensing.
Coordinate and participate in regulatory agency audits, in support of the Akorn Agent In Charge, and as directed by the CEO

Desired Skills and Experience
BS degree is required along with at least 10+ years of direct experience in finished dosage sterile drug manufacturing. Previous experience working directly for the FDA is a plus (CDER, CBER, OGD, CDRH, etc)

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