Sr Manager, QA-GMP Mfg. Compliance - 2266

ICOS Corporation, based in the Seattle, Washington area, has spent more than a decade building a world-class research and development organization. Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.

Responsibilities:
To support the growing complexity and diversity of the ICOS clinical product manufacturing program, we are seeking a Sr. Manager, QA-GMP Manufacturing Compliance. In this highly visible role, you will have a significant impact working on manufacturing quality initiatives, and involvement on the direction and development of the company?s quality assurance programs.

This position offers you the opportunity to work in a diverse environment working on projects that include internal manufacturing, contract manufacturing, participation on CMC teams, as well as quality assurance issues associated with transition from product development to clinical production.

If you want to be a part of an exciting QA organization, use your strategic, tactical and management skills, and want to influence change, this may be the position for you.

The successful candidate will be responsible for providing management of compliance programs for the manufacture of clinical trial materials at the ICOS facility. Specific responsibilities include:

?Manage team responsible for all GMP quality assurance activities associated with the production and release of clinical trial materials for contracted clients and internal use
?Review and/or coordinate review of ICOS and client change requests including master batch records, specifications, test methods, and supporting SOPs
?Coordinate and perform QA support activities for clinical trial material manufacturing facility
?Represent QA on client product development teams
?Represent QA on quality improvement teams
?Manage and coordinate efforts of the QA staff
?Mentor and train QA staff
?Prepare department QA budget

Requirements:
?BS in a relevant scientific discipline
?Ten + years experience in clinical or commercial pharmaceutical manufacturing
?Five + years experience in QA
?Experience with QA/GMP compliance in early and late phase clinical trial material manufacturing and contract manufacturing
?Working knowledge of GMPs for APIs (ICH Q7A) and Drug Products, an understanding of basic scientific principles, and a sound understanding of quality systems
?Ability to evaluate documentation/operating procedures against Company and regulatory guidelines
?Previous biologics manufacturing and/or QC experience preferred
?Proven ability to lead, manage and mentor a team
?Computer literacy required
?Strong interpersonal, written and oral communication skills
?Strong problem solving skills

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

For immediate consideration please email your CV to Karen Fenstermacher at kfenstermacher@icos.com highlighting the position in the subject line or visit www.icos.com and apply directly for this position.

Learn more about ICOS philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com
To Apply for this position, please CLICK HERE