Quality and Regulatory Manager

Isis Pharmaceuticals, Inc. is a leading drug discovery and development company, focused exclusively on the therapeutic target, RNA. Founded in 1989, Isis' mission is to develop products from its RNA-based technologies, such as antisense. Very little was known about antisense when the Company was first established, but its founders envisioned an opportunity to revolutionize the pharmaceutical industry with a more efficient and targeted means of drug discovery. Since then, Isis scientists have made tremendous progress advancing the science of antisense, unveiling capabilities that have far exceeded their expectations.

Ibis Therapeutics, a division of Isis Pharmaceuticals Inc., plans to be the market leader in selling products for the identification of infectious organisms for a wide range of applications.

 

Quality and Regulatory Manager

 

Take a shot at an opportunity to create an entire Quality Organization from the ground up.  We have an exiting new technology for the identification of infectious organisms using PCR and Mass Spec.  We are just beginning to commercialize the product and are looking for a multi-talented person to build the Quality System and Quality Organization.

 

Primary Responsibilities

In this start-up organization, the incumbent will be responsible for the quality and regulatory functions.  This will include creation of systems and writing procedures including but not limited to; product release, quality policy, and all documentation for FDA and ISO compliance.  Initially responsible for the direct testing and release of raw materials and manufactured product.  Maintain records and retention samples as necessary.  Oversee regulatory shipping requirements and documentation for US and international compliance.  Position will be responsible for organizing, hiring, staffing and managing, as business need arise, all regulatory, quality control and quality assurance functions.  Responsible for quality and regulatory departmental budgeting and budget compliance.  Incumbent will initially report to the Director of Operations.

 

Requirements

? Organized and detailed.

? Experience in establishing FDA/ISO compliance.

? Should have good lab skills and experience working in a clean room environment.

? Experience in nucleic acid based diagnostics desired.

? Position requires five plus years of quality management and/or regulatory experience.  BS degree is required.  

? Degree or certification in quality assurance, quality control or regulatory compliance is also preferred.

? US citizenship required (due to government contract stipulations).

 

 

 

Excellent salary and benefits package offered.

 

For immediate consideration, please apply online by visiting our website, www.isispharm.com.  Reference job code:  0627 NO PHONE CALLS PLEASE.  PRINCIPALS ONLY.  Isis Pharmaceuticals, Inc. is an AA/EEO Employer.