Director Quality Compliance, Audit and Inspections Global Process Owner
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Director Quality Compliance, Audit and Inspections Global Process Owner
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible for defining approaches and ensuring the design of the Audits and Inspection program effectively advances Amgen strategies for sustainable compliance. Preemptively monitor and successfully communicate quality compliance performance indicators to Amgen Quality Leadership and Executive Management. Function as a member of the review team in charge of assessing potentially reportable deviations.
When requested, act as a back-up attendee to the recall executive committee. Present regulatory advice to internal partners on matters of significant complexity. Through exhibited leadership skills, maintain an apt network including Amgen Operations and R&D leaders to ensure a fit for purpose quality compliance program.
Will consider remote locations.
- Ensure the design of Amgens Audit and Inspection program is suitable and effective to advance compliance with GxP (GLP, GCP, CPvP, GMP, GDP) requirements at an enterprise level
- Maintain a strong network to promote a patient centered quality culture, drive and seek alignment of standard methodologies for conducting internal audits and leading regulatory inspections
- Own relevant global documents and ensure alignment with the Quality Management System (QMS) architecture
- Cascade defined audit and inspection process strategy for appropriate execution to site and functional Subject Matter Experts (SMEs) and corresponding leadership for deployment of the quality compliance program architecture
- Timely engage and notify sites and/or functional groups of programmatic changes to ensure understanding and consistent performance
- Ensure visibility and oversight to major changes across operations to ensure applicability and consistent performance of matters related to audits and inspections
- Purposefully analyze and effectively present quality compliance performance indicators to Amgen Quality Leadership and Executive Management to establish appropriate corrective/preventive actions
- Own and communicate metrics that provide visibility to quality compliance performance throughout the operation. Oversee overall performance and delivery of quality commitments in alignment with Quality strategies and with focus on continuous improvement
- Play a leading role in creating awareness of emerging regulatory trends that are relevant to advance Amgen GxP compliance
- Serve as a member of the review team in charge of assessing potentially reportable deviations. In this capacity provide advice with respect to quality compliance and reporting regulatory requirements, as appropriate
- Draft and/or review correspondence to Health Authorities related to post-market reports or resulting from inspections
- As a trusted partner, drive continuous improvement
- Listen to diverse groups of backgrounds and listens to differing views
Doctorate degree and 4 years of Quality, Regulatory, Compliance or Operations experience
Masters degree and 8 years of Quality, Regulatory, Compliance or Operations experience
Bachelors degree and 10 years of Quality, Regulatory, Compliance or Operations experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
We are all different, yet we all use our unique contributions to serve patients. The Compliance professional we seek has a keen sense of business with the following qualifications.
10+ years experience Compliance, Quality in medical device/combination products/pharmaceutical/biotech industry
Exceptional knowledge in combination product regulatory requirements
In-depth working knowledge of US and worldwide GxP regulations
Ability to build positive relationships to foster a collaborative approach to proactive compliance activities
Ability to prioritize multiple priorities, projects, and team members, as well as adapt to changing business needs
Excellent communication skills; including technical writing and presentation skills
Demonstrated teamwork and mediation skills; ability to work through conflicting situationsThrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
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 a 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 an accommodation.
Join UsIf 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.