Quality Compliance Senior Manager

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

Descripción de la vacante

A leading biotechnology company seeks a Quality Compliance Senior Manager to oversee quality processes in clinical trials. The role requires at least 7 years of experience in Quality Management within the pharma/biotech sector, focusing on risk-based quality strategies and compliance oversight. Candidates should possess strong leadership and communication skills, along with familiarity with electronic QMS systems like Veeva or TrackWise.

Servicios

Healthcare benefits

Financial benefits

Career development opportunities

Formación

• 7+ years in Quality Management or Assurance within pharma/biotech.
• Experience with regulatory submissions and inspections.
• Familiarity with electronic QMS systems.

Responsabilidades

• Oversee end-to-end quality processes in clinical trials.
• Provide quality oversight and conduct GCP audits.
• Manage regulatory inspections and guide responses.

Conocimientos

Leadership

Communication

Risk Management

Quality Assurance

Regulatory Compliance

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

The Quality Compliance Senior Manager will oversee end-to-end quality processes within one of four Therapeutic Areas (TAs): Oncology, Rare Diseases, General Medicine, Inflammation and Biosimilars. You will support risk-based quality strategies throughout the clinical trial lifecycle, from protocol development to regulatory approval, developing expertise in clinical trials and managing 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. Provide quality oversight across all stages of clinical development.
3. Plan, conduct, and report on risk-based GCP audits or support outsourced audits.
4. Manage regulatory inspections and guide responses to health authorities.
5. Oversee the Risk Assessment Categorization Tool (RACT) for each trial.
6. Review quality and compliance risks in monthly meetings with clinical program leaders.
7. Address audit findings and deviations, supporting corrective actions.
8. Establish regional expertise to ensure compliance with local regulations.
9. Conduct vendor qualifications and evaluations based on risk.
10. Analyze data quality indicators, trends, and recommend improvements.
11. Support TA-specific oversight of key technologies and develop Quality Assurance plans.
12. Assist Clinical Trial Teams with quality management activities.
13. Implement innovative quality oversight methodologies.
14. Review clinical trial protocols to identify critical data and processes for risk management.
15. Manage analytical tools and data quality trends across therapeutic areas.
16. Provide oversight for key target sites and communicate findings to promote compliance and best practices.
17. Offer independent, objective quality consultation and support vendor assessments.
18. Report compliance metrics and maintain knowledge of current regulatory and quality practices.
19. Lead pre-inspection and mock inspection visits to sites and affiliates.

WHAT WE EXPECT OF YOU

We seek a candidate with technological literacy and leadership skills, with 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 systems like Veeva or TrackWise, and a strong understanding of Clinical R&D and global regulations are essential. Experience with regulatory submissions and inspections, quality oversight of clinical trials, and excellent communication skills are also required.

THRIVE

We value our team members’ professional and personal growth, offering opportunities to learn, develop, and advance within our global organization. We promote a diverse, inclusive community where ideas are shared freely, and innovation is encouraged. Our comprehensive rewards plan includes healthcare, financial, and career 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 without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. Reasonable accommodations are provided for individuals with disabilities during the application and interview process. Please contact us to request accommodations.

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