Amgen

Sr Manager Quality Assurance, Drug Product

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 20, 2019
Ref
R-80181
Required Education
Bachelors Degree
Position Type
Full time
Reporting to the QA Director, the QA Senior Manager, Drug Product, effectively manages the

daily work of direct reports responsible for the quality oversight of Drug Product Formulation

and aseptic Fill Finish activities in the Drug Product Manufacturing facility at Amgen,

Thousand Oaks. The QA Senior Manager will also be responsible for advancing quality

systems, batch record review, investigations and managing change within the Drug Product

facility.

Key responsibilities:
  • Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Keep up to date with emerging trends and regulatory advances in the areas of aseptic processing and drug product inspection and ensure appropriate staff development and training in areas of responsibility.
  • Perform review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Non-conformances, CAPAs, and validation activities.
  • Champion Continuous Improvement initiatives, programs and projects.
  • Ensure that changes that could potentially impact product quality are assessed according to procedures.
  • Ensure that deviations from established procedures are investigated and documented per procedures.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
  • Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations.
  • Alert senior management of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units. Exercise judgment independently.
  • Represent the quality unit during audits and inspections as needed.
  • Support internal/external audits and inspections as part of the audit/inspection management team as needed.
  • Complete required assigned training and manage team training to permit execution of required tasks.


Basic Qualifications:

Doctorate degree and 2 years of Quality experience

OR

Master's degree and 6 years of Quality experience

OR

Bachelor's degree and 8 years of Quality experience

OR

Associate's degree and 10 years of Quality experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:
  • 5+ years of Quality experience
  • 2+ years of Management at a senior quality level
  • Experience in aseptic processing, sterilization practices and processes
  • Experience interacting with multiple sites
  • Working/detailed knowledge of GMPs and global QA requirements as related to aseptic processing in US and multiple jurisdictions
  • Proven leadership and organizational skills
  • Skilled in technical writing and critical thinking
  • Computer Skills: Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Electronic Document Management System (EDMS).
  • Good organizational, communication and presentation skills, effective project and time management skills, and ability to work well under pressure.
  • Excellent attention to detail
  • Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment


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.