Quality Compliance Senior Manager

Amgen SA; Bilbao; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Amgen is seeking a Quality Compliance Senior Manager to oversee quality oversight within therapeutic areas, ensuring compliance and managing audits. The ideal candidate will have over 7 years of experience in Quality Management within the pharma/biotech sector, demonstrating strong leadership and communication skills.

Servicios

Comprehensive rewards and benefits

Opportunities for professional growth

Diverse and inclusive community

Formación

• At least 7+ years in Quality Management or Assurance within pharma/biotech.
• Experience with regulatory submissions and inspections.
• Strong understanding of Clinical R&D and regulations.

Responsabilidades

• Serve as a GCP Subject Matter Expert for clinical trial activities.
• Oversee quality for Amgen's clinical development programs.
• Plan and conduct risk-based GCP audits.

Conocimientos

Leadership

Communication

Technological literacy

Herramientas

Veeva

TrackWise

Descripción del empleo

At Amgen, every challenge is an opportunity. Our shared mission—to serve patients—drives all that we do. We are a global biotechnology company committed to researching, manufacturing, and delivering innovative products to over 10 million patients worldwide. Join us for a career you can be proud of.

QUALITY COMPLIANCE SENIOR MANAGER

LIVE

WHAT YOU WILL DO

Support end-to-end quality oversight within one of four Therapeutic Areas (Oncology, Rare Diseases, General Medicine, Inflammation and Biosimilars). You will implement a risk-based quality strategy throughout the clinical trial lifecycle, from protocol development to regulatory approvals, and oversee data and processes for global and local study teams and trial sites involved in Amgen-sponsored trials.

Responsibilities:

1. Serve as a GCP Subject Matter Expert, providing independent quality advice for clinical trial activities.
2. Oversee quality for Amgen's clinical development programs.
3. Plan and conduct risk-based GCP audits, including supporting outsourced audits.
4. Manage regulatory inspections and guide responses to health authorities.
5. Oversee the Risk Assessment Categorization Tool (RACT) for each trial.
6. Participate in monthly meetings with clinical program leaders to review quality and compliance risks.
7. Develop responses for audit findings and deviations.
8. Establish regional expertise to ensure local compliance.
9. Conduct vendor qualifications and evaluations risk-based.
10. Analyze data quality indicators and trends, recommend corrective actions, and communicate metrics to stakeholders.
11. Support oversight of key technologies for data collection and measurement.
12. Develop TA-specific Quality Assurance plans.
13. Assist Clinical Trial Teams with quality management activities.
14. Implement innovative quality oversight methodologies.
15. Review protocols for risk management and simplification.
16. Manage analytical tools and data quality trends across therapeutic areas.
17. Provide quality oversight for key target sites and communicate findings to promote compliance and best practices.
18. Offer independent quality consultation for clinical trials.
19. Support local vendor assessments and communicate compliance metrics.
20. Maintain current knowledge of regulatory and quality practices, providing ongoing training.
21. Lead pre-inspection and mock inspection visits to sites and affiliates.

WHAT WE EXPECT OF YOU

We seek individuals with technological literacy, leadership skills, and at least 7+ years in Quality Management or Assurance within pharma/biotech, focusing on risk-based quality and design. Leadership and mentoring experience, familiarity with electronic QMS (like Veeva or TrackWise), and strong understanding of Clinical R&D and regulations are essential. Experience with regulatory submissions and inspections, protocol development, and excellent communication skills are also required.

THRIVE

We prioritize our teammates’ professional and personal growth, offering opportunities to learn, develop, and advance within our global organization. We foster a diverse, inclusive community and provide comprehensive rewards and benefits.

APPLY NOW

Objects in your future are closer than they appear. Join us at careers.amgen.com.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer. We consider all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are available for individuals with disabilities upon request.