ICOS Corporation

Manager, Quality Assurance Validation

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.

Experience in the management of a Quality Assurance Validation group within the Pharmaceutical, Biotech or other FDA regulated industry. Ability to work in the fast paced environment of a growing company and changing regulatory requirements as API and drug product progress from development to commercialization.

Responsibilities:

Primary responsibilities: Provide QA validation management and support for activities involving clinical manufacturing, analytical laboratories and transitional process development areas including:

• Provide technical expertise to all ICOS validation/qualification activities.
• Provide technical guidance on regulatory requirements, guidance documents and industry standards relevant to validation/qualification activities.
• Assure compliance and maintenance of validation systems.
• Strong knowledge and experience in change management of validated equipment, utilities, and analytical instruments to evaluate and assess appropriate qualification/re-qualification requirements.
• Review, approve, source and/or write validation documents. (Master Validation plans, IQ, OQ, PQ).
• Manage the execution of validations/qualifications, validation protocols, Master Validation plans to meet company objectives.
• Recommend and/or implement resolutions to technical validation/qualification issues with internal/external sources.
• Manage/track Master Validation Plan.
• Generate metrics for validation projects and quarterly reports to management.
• Understanding of 21 CFR Part 11 requirements.
• Schedule requalification/recertification studies and maintain associated database.

Requirements:

• Minimum 8 years experience in a validation role with in the Pharmaceutical or Biotech industry.
• Bachelor's degree in sciences (Engineering, Biology, Chemistry etc.).
• Minimum 5 years supervisory experience.
• Knowledge of GMP's required (GLP, ICH, ISPE, PDA desirable).
• Experience with maintenance and compliance of validation systems.
• Strong interpersonal and communication skills.

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

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.

ICOS Corporation
Reference Job Code: 2287
Karen Fenstermacher

Email: kfenstermacher@icos.com

ICOS Corporation is an Equal Opportunity Employer

Submitted: 11/22/2005