QA Disposition Manager

In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.

The Quality Assurance Disposition Manager is responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, dispositioned and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Other responsibilities include:

• Responsible for Quality disposition (approval or rejection) of raw materials and components, cell banks, bulk drug substances, bulk drug products, and finished product for assigned areas.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, and validations.
• Supports Continual Improvement initiatives, programs and projects.
• Ensures that changes that could potentially impact product quality are assessed according to procedures.
• Ensures that deviations from established procedures are investigated and documented per procedures.
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
• Collaborates cross functionally and across the Amgen Enterprise/Network to ensures the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations.
• Alerts senior management of significant quality, compliance, supply and safety risks.
• Represents the quality unit during audits and inspections as needed.
• Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
• Completes required assigned training to permit execution of required tasks.
• Performs additional duties as specified by management.

Basic Qualifications:

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 Qualifications:

• Experience with the review and Disposition of batches for all phases of drug development.
• Experience with TrackWise for supporting Nonconformance investigations, CAPA, Change Control, Complaints
• Experience with cGMP Production Environments
• Experience with SAP and Supply Chain concepts
• Demonstrated ability with project management, initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
• Good understanding of cGMP and regulatory requirements
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
• Analysis of complex problems and delivery of clear and timely feedback
• Strong interpersonal skills
• Application of project management principles and techniques
• Biology, Chemistry, or Engineering degree is desirable

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.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.