Amgen Engineering Compliance Manager in Thousand Oaks, California

Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.

Engineering Strategic Planning and Operations continuously drives improved Engineering performance through training programs, monitoring of business performance, inspection readiness and response, risk management, and safety programs.

Amgen is seeking a Compliance Manager to join the Engineering organization. The Compliance Manager role will be responsible for supporting all aspects of compliance throughout the inspection lifecycle and maintaining inspection readiness within the Engineering organization. The scope of compliance within Engineering includes GMP, GLP, financial and Environmental Health, Safety and Sustainability (EHSS) audits and inspections. Duties include:

  • Lead Engineering teams to identify key compliance issues, formulate a strategy to address these issues, and communicate strategy to senior management

  • Direct inspection preparation activities, such as compliance assessment plans, playbooks and overview presentations

  • Serve as the point of contact between Engineering and inspectors/ auditors

  • Assist Engineering functions to develop annual inspection readiness strategies and support planned inspection readiness activities

  • Oversight for deviation triage and management

  • Educate staff on compliance requirements

  • Lead Engineering teams in the formulation of audit responses to ensure observations are addressed in a strategic and systematic manner and track commitments to closure

  • Generate and own inspection management policies, procedures, and practices

  • Lead cross functional forums to maintain a compliant network, resolve issues, and share best practices

  • Foster a working relationship between Engineering and auditing functions such as Quality and Environmental Health, Safety and Sustainability (EHSS)

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Engineering or Operations- related experience

OR

Bachelor's degree and 5 years of Engineering or Operations- related experience

OR

Associate's degree and 10 years of Engineering or Operations- related experience

OR

High school diploma / GED and 12 years of Engineering or Operations- related experience

AND

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

Preferred Qualifications:

  • Knowledge of GMP/ GLP regulatory requirements and/ or Quality Management processes

  • Knowledge EHSS/ safety requirements

  • Experience having direct interactions with regulatory agencies

  • Audit management experience (internal and/ or regulatory)

  • Demonstrated knowledge/experience of Continuous Improvement methodologies and tools

  • Ability to effectively communicate with varied client base, including all Engineering teams, auditors and management.

  • Six Sigma certification (green belt or black belt)

  • Experience managing improvement initiatives

  • Basic understanding of Engineering functions such as equipment maintenance, facilities maintenance and capital construction projects.

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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.

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.