Quality Compliance Senior Manager | GK650

Amgen

  • Buenos Aires
  • Permanente
  • Tiempo completo
  • Hace 1 día
Join Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.LiveWhat you will doLet’s do this! Let’s change the world! The role provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program.The role will support end to end quality oversight of the General Medicine & Obesity Therapeutic Area and will be responsible for supporting a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).You will play a vital role by developing deep knowledge of the clinical trials you support and provide oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.Responsibilities- Act as a Good Clinical Practice (GCP) Subject Matter Expert, offering independent, objective quality guidance.
- Oversee quality across all clinical development stages.
- Plan and execute risk-based GCP audits (sites, affiliates, vendors, studies).
- Support regulatory inspections and guide responses, including root cause analysis and CAPAs.
- Lead quality oversight of Risk Assessment Categorization Tools (RACT) for each trial.
- Facilitate monthly quality risk reviews with clinical program leaders.
- Manage audit findings, deviations, and CAPA responses.
- Ensure regional compliance with local regulations and support vendor evaluations.
- Analyze data quality trends, identify gaps, and implement corrective actions.
- Oversee technologies for endpoint data collection (e.g., biomarkers, imaging).
- Develop and execute TA-specific QA plans and protocol-specific audit strategies.
- Support quality management activities including deviations, breaches, and inspection readiness.
- Drive innovation in quality oversight using data analytics, AI, and NLP.
- Review protocols to simplify design and identify critical data/processes.Country/ Regional Quality Leadership- Manage analytical tools and data trends to address site/regional quality gaps.
- Provide oversight for key sites in collaboration with regional operations.
- Share best practices and compliance insights with stakeholders.
- Offer independent quality consultation and escalate issues as needed.
- Support local vendor assessments and pre-inspection activities.
- Conduct regional risk assessments for audit planning.
- Stay current on regulatory trends and deliver ongoing training.WinWHAT WE EXPECT OF YOUWe 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 and 2 years of Quality Management, Quality Assurance and Good Clinical Practices experience in the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.OrMaster’s degree and 4 years of the previous mentioned experienceOrBachelor’s degree and 6 years of the previous mentioned experienceOrAssociate’s degree and 10 years of the previous mentioned experience- Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
- Thorough understanding of Clinical R&D; activities and Global Regulations.
- Experience with Regulatory Submission and Inspection Management procedures.
- Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
- Leadership or mentoring experience is ideal, in a regional capacity would be phenomenal.
- Excellent verbal and written communication skills, including strong business writing abilities and active listening. Able to understand and articulate technical concepts and literature in spoken and written English.
- Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
- Self-driven with strong analytical, critical-thinking, prioritization, and decision-making abilities.IMPORTANT! Please submit your resume/CV in English!ThriveWHAT YOU CAN EXPECT OF US- Vast opportunities to learn, develop, and move up and across our global organization.
- Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
- Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits.
- Flexible work arrangements.Apply nowIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us: Careers.amgen.comAs 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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.

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