Quality Compliance Senior Manager
Quality Compliance Senior Manager
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Job Description
Career Category
QualityJob Description
At Amgen every challenge is an opportunity. 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 everbetter products that read over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
QUALITY COMPLIANCE SENIOR MANAGER
LIVE
WHAT YOU WILL DO
Lets do this. Lets change the world. In this vital role the Quality Compliance Senior Manager will support endtoend quality oversight within one of four Therapeutic Areas (TAs): Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars. You will support a riskbased quality strategy throughout the clinical trial lifecycle from protocol development to regulatory approvals.
You will develop indepth knowledge of clinical trials and oversee data and processes for global and local study teams and trial sites involved in Amgensponsored 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 riskbased 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 compliancerelated risks.
Support response generation for audit findings and selfreported deviations.
Support the establishment of regional expertise to ensure quality and compliance with local regulations.
Conduct new vendor qualifications/evaluations in a riskbased manner.
Prepare analyze and identify data quality indicators/trends recommend and implement corrective actions and communicate quality metrics to key stakeholders.
Support TAspecific oversight of key technologies including technologies for endpoint data collection and measurement.
Support the development of TAspecific 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 preinspection/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 riskbased 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 criticalthinking and decisionmaking 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 wellbeing.
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.
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 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.
Required Experience:
Senior Manager
Employment Type
Full-Time
