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Engineering Compliance Manager

Employer
Amgen
Location
Thousand Oaks, CA
Start date
Sep 19, 2021

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge youre working hard to acquire and the passion you already have. 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. Through this role, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Live

This could be your everyday

Lets do this. Lets change the world. A successful candidate will provide leadership for the Engineering Compliance Program - supporting all aspects of GXP and Safety compliance and maintaining inspection readiness across the Engineering organization globally. This role is going to make a difference!

This position interacts with all levels of the organization, and responsibilities will include:

  • Lead Engineering teams to identify compliance issues, formulate a strategy to address these issues, and communicate strategy to senior management
  • Lead cross functional teams to maintain a compliant network, resolve issues, and share best practices
  • Serve as the main point of contact between Engineering and auditing functions such as Quality and Corporate Quality Compliance (CQC)
  • Assist Integrated Service Providers (ISPs) and Engineering functions to develop annual inspection readiness strategies and support planned inspection readiness activities
  • Direct inspection preparation activities, such as developing assessment plans and coaching SMEs
  • Facilitate monthly cross functional Engineering Compliance meetings
  • Maintain oversight for deviation triage and management
  • Educate staff on compliance requirements
  • Lead Engineering teams in the formulation of audit responses and track commitments to closure
Win

Heres what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The Engineering Compliance Manager we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality and/or Engineering experience
OR
Masters degree and 6 years of Quality and/or Engineering experience
OR
Bachelors degree and 8 years of Quality and/or Engineering experience
OR
Associates degree and 10 years of Quality and/or Engineering experience
OR
High school diploma / GED and 12 years of Quality and/or Engineering experience

Preferred Qualifications:

  • Knowledge of GMP/ GLP regulatory requirements and Quality Management processes
  • Experience having direct interactions with regulatory agencies
  • Experience in GMP Manufacturing, GMP Maintenance or Quality
  • Audit management experience (internal and/ or regulatory)
  • Ability to effectively communicate with varied client base and all levels of the organization, including all Engineering teams, auditors, Integrated Service Providers (ISPs) and senior leadership
  • Experience with data analytic tools such as Tableau or Spotfire a plus
  • Demonstrated knowledge/experience of Continuous Improvement methodologies and tools

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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 requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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