Compliance Manager

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Live

What you will do

Lets do this. Lets change the world. In this vital role, the Research Quality strategy is focused on unregulated and regulated research at Amgen, including Good Laboratory Practice (GLP), spanning from discovery through the entire lifecycle of development. This strategy will ensure that all research methods at Amgen meet internal and external quality standards, and encompasses laboratory procedures, equipment and systems for research activities performed internally and through third-party vendors/suppliers. Maintaining the integrity of research data will be a key focus of this role, including data generated in collaborations as well as through third parties. In this vital role, you will be responsible to:

• Develop collaborative partnerships with R&D and Quality to ensure a constant state of quality, escalate potential areas of quality risk exposure, and innovate to improve the overall quality within the dynamic R&D environment.
• Ensure research activities maintain compliance to relevant laws, regulations, and internal quality standards, while ensuring the ethical treatment of research animals, and the integrity of all generated data.
• Conduct audits to determine if all experimental study phases were performed according to the principles of Good Laboratory Practice. Promptly escalate the outcome of the audits in writing to the Test Site Management, the Principal Investigator, the Study Director and, if applicable, the Management of the Study Director.
• Manage and track deliverables, monitor trends and provide data and recommendations regarding the state of quality for internal processes, technology, laboratory, and external vendor performance related to research activities.
• Provide knowledge of biotechnology research, with a strong understanding of, but not limited to; drug development, orphan drug development, regulated research, Good Laboratory Practice (GLP) and unregulated research from discovery through development.
• Account for the risk assessment of internal processes, technology, laboratory, and external vendors so that they are aligned with Research and Development leadership and Operations so that the quality assurance and quality management systems are efficient and effective.
• Ensure the management of the QMS related to research activities, including the audit plan development and execution across Amgen and its partners/third parties, and Deviations/CAPA that result from all audits and inspection activities.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Doctorate degree

Masters degree and 2 years of life science, technology, and/or project management experience

Bachelors degree and 4 years of life science, technology, and/or project management experience

Associates degree and 8 years of life science, technology, and/or project management experience

High school diploma / GED and 10 years of life science, technology, and/or project management experience

• Educated in a science field with at least three (3) years of experience working in GxP relevant Quality Assurance roles within regulated industry.
• Experience with compliance to Good Laboratory Practices, including partnership with third-party vendors, suppliers, and partners.
• Demonstrated ability to perform GxP related audits as well as follow detailed SOPs, maintaining training, and adhering to good documentation practices.
• Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)
• Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent.
• Ability to optimally prioritize a diverse workload to meet deadlines and collaboration expectations.
• Great attention to detail and high degree of accuracy in task execution and documentation
• Highly effective verbal communication skills, strong interpersonal skills
• Ability to complete tasks autonomously, provide updates to manager, and identify potential issues.
• Strong analytical, critical-thinking, and decision-making abilities.
• Capability to understand and articulate technical concepts and literature in spoken and written English.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.