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Job Information (#542)

Job Title:

Quality Assurance Director Complaints

Job Code:

20698

Job Location:

Puerto Rico

Required Education:

Bachelors Degree

Years of Experience:

Travel:

None

Salary:

Based on Experience

# of Openings:

Description:

This position requires strong leadership skills in combination with project management skills. The position will entail managing and developing Complaint Investigation staff and supporting the product complaint system at Amgen. Other responsibilities may include: Data management and presentation, leading operational excellence initiatives and management review of complaints and investigations.

Candidate must possess experience in leading investigations, in depth knowledge of fill/finish operations and/or incoming component inspection/disposition, effective decision making and influencing skills, and ability to manage a large number of complex projects simultaneously.
Bachelor’s degree in Biological Sciences or related field
10+ years of biopharmaceutical experience with increasing responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
5 + years of Management experience is required.
Demonstrated ability to lead and develop staff. Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must. Excellent written and verbal communication skills, including facilitation and presentation skills. Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
Demonstrated experience in leading investigations (deviations and/or complaints)
Demonstrated experience achieving results and in identifying areas of process improvement.
Understanding of biopharmaceutical bulk and drug product manufacturing and distribution processes.
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
Experience in leading product complaints processing and investigation required.
Advanced knowledge of U.S. and International regulations and practices pertaining to the manufacture and testing of pharmaceutical/biological products.
Proven interactions with regulators both verbally and in writing.

Skills:

Microsoft Word	Microsoft FrontPage	Database
Microsoft Excel	Visio	Windows 2000
Microsoft PowerPoint	Internet Explorer	Windows XP
Microsoft Access	Lotus Notes	Windows 98
Microsoft Project	Microsoft Outlook	Windows NT

Attached Document:

Not Available

Date Posted:

7/23/2010