Quality Compliance Senior Manager

At Amgen, every challenge is an opportunity. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
QUALITY COMPLIANCE SENIOR MANAGER

LIVE
WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role the Quality Compliance Senior Manager will support end-to-end quality oversight within one of four Therapeutic Areas (TAs)**:Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars.** You will support a risk-based quality strategy throughout the clinical trial lifecycle, from protocol development to regulatory approvals.
You will develop in-depth knowledge of clinical trials and oversee data and processes for global and local study teams and trial sites involved in Amgen-sponsored trials.

**Responsibilities**:

- Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities.
- Provide quality oversight for Amgen programs for all stages of products in clinical development.
- Plan, conduct, and report on risk-based GCP audits or support outsourced audits.
- Manage/support regulatory inspections and provide guidance on responses to health authorities.
- Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial.
- Support monthly meetings with clinical program leaders to review quality and compliance-related risks.
- Support response generation for audit findings and self-reported deviations.
- Support the establishment of regional expertise to ensure quality and compliance with local regulations.
- Conduct new vendor qualifications/evaluations in a risk-based manner.
- Prepare, analyze, and identify data quality indicators/trends, recommend and implement corrective actions, and communicate quality metrics to key stakeholders.
- Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement.
- Support the development of TA-specific Quality Assurance plans.
- Support Clinical Trial Teams for all quality management activities.
- Actively seek and implement innovative and proactive quality oversight methodologies.
- Review clinical trial protocols ensuring simplification and identification of critical data and processes for risk management activities.
- Manage the framework of analytical tools and data quality indicators/trends across therapeutic areas.
- Provide quality oversight primarily for key target sites
- Communicate findings to drive compliance and share best practices.
- Provide independent, objective quality consultation to the business in support of clinical trials.
- Provide support for local vendor assessments.
- Prepare, analyze, and communicate compliance metrics to key stakeholders.
- Maintain knowledge of current regulatory and quality practices/issues and provide continuous training and education.
- Lead pre-inspection/mock inspection visits to sites/affiliates.
- Run regional risk assessments for audit target identification.

WIN
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:

- 7+ years in Quality Management or Assurance in pharma/biotech, focusing on risk-based quality and design.
- Leadership and mentoring experience.
- Oversight and implementation of Quality Management Systems, familiar with electronic QMS like Veeva or TrackWise.
- Strong understanding of Clinical R&D and Global Regulations.
- Experience with Regulatory Submissions and Inspections.
- Quality Oversight of Clinical Trials, including protocol development and implementation.
- Excellent verbal and written communication skills, business writing, and active listening.
- Ability to simplify business and stakeholder feedback into clear processes.
- Strong analytical, critical-thinking, and decision-making skills.
- Ability to articulate technical concepts in English.

THRIVE
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, develop, and move up and across our global organization.
- A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, try new things, and act.
- Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
- Flexible work arrangements.

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

EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex