Manager QA

Supervise a work-group of complaint investigators which drives compliant documentation of customer complaints for a particular set of products.

• Ensures quality of tasks and complaint records
• Leads group initiatives
• Ensures execution of regulatory and SOP requirements
• Conducts complaint investigations as appropriate
• Sets record timelines and priorities
• Provides guidance and technical advice
• Staff member supervision (4-10 staff members)
• Escalates potential Quality issues to Sr. Management
• Lead team's performance and oversight of staff's performance and development
• Financial oversight / team's budget management
• Provides work assignments
• Approves quality record content
• Represents department in project teams
• Determines strategy for improving group performance
• Approve complaint records
• Actions which improve efficiency of work group
• Provides data and metrics
• Reports into the Sr. Manager QA - Complaints
• Manages a team of Associates / Sr. Associates / Specialists
• Drives strategy in combination with supervisor
• Sets priorities based on established timelines
• Works with site leads to obtain assessments of contributing factors

Basic Requirements

Doctorate degree

OR

Master's degree and 3 years of Quality experience

OR

Bachelor's degree and 5 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

OR

High school diploma / GED and 12 years of Quality experience

Preferred Requirements:

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor's Degree in a Science Field
• Leadership skills
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to operate in a matrix or team environment with site, functional, and executive leadership
• Experience in driving decision making by using the DAI principles
• Understanding of quality requirements
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Lead and motivate a team
• Technical expertise and application
• Problem solving and decision making
• Judgment and discretion
• Interpersonal skills and communication
• Ability to drive continuous improvements
• Operational excellence mind-set

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.