Principal Corporate Quality Compliance vacancy at Amgen in Seattle

Amgen is looking of Principal Corporate Quality Compliance on Sat, 08 Sep 2012 00:12:04 GMT. Coordinate and lead, or participate in, Corporate Quality Compliance audits of Amgen sites and contract facilities, including laboratories, manufacturers, service providers and quality systems. Apply an advanced knowledge of current regulatory regulations, standards and guidelines, in addition to requirements of applicable SOPs, in the conduct of these audits. • Review and assess new or revised...

Principal Corporate Quality Compliance

Location: Seattle Washington

Description: Amgen is looking of Principal Corporate Quality Compliance right now, this vacancy will be placed in Washington. More details about this vacancy opportunity please give attention to these descriptions. Coordinate and lead, or participate in, Corporate Quality Compliance audits of Amgen sites and contract facilities, including laboratories, manufacturers, service providers and quality systems. Apply an advanced knowledge of current regulatory regulations, standards and guidelines, in addition to requirements of applicable SOPs, in the conduct of these audits.

• Review and assess new or revised regulations, standards, and guidelines as related to product testing; provide sites with guidance on new regulatory compliance expectations and trends.
• Provide leadership toward resolving site and multi-site compliance risks.
• Provide compliance support for product quality teams.
• Perform tasks and participate on project teams as assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
• May provide support for regulatory inspections of Amgen facilities.
• Travel to domestic and international to Amgen and vendor locations. Basic Qualifications • Doctorate degree & 2 years of directly related experience

OR

• Master’s degree & 6 years of directly related experience

OR

• Bachelor’s degree & 8 years of directly related experience

OR

• Associate’s degree & 10 years of directly related experience

OR

• High school diploma / GED & 12 years of directly related experience Preferred Qualifications • MS degree and 8 years of related experience in a regulatory compliance position supporting the manufacture and testing of pharmaceutical products.
• Experience performing GMP audits of manufacturers of biologic and small molecule API and DP, and laboratories that perform testing for API and DP.
• Advanced knowledge of U.S. and European regulations, compendia, guidance and industry practice as pertains to the manufacture and testing of biological products.
• Demonstrated advanced ability to evaluate and apply regulatory requirements and guidelines to applicable situations.
• Excellent verbal and written communication skills, including technical writing.
• Strong ability to lead teams and effectively utilize team resources.
• Ability for overnight travel domestic and international about 35%.

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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Amgen.

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This vacancy starts available on: Sat, 08 Sep 2012 00:12:04 GMT

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