Quality Compliance Manager Snr Manager

Career Category

Job Description

Taiwan

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds leading independent biotechnology companies. For over 4 decades Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a (Sr.) Quality Compliance Manager.

Live

What you will do

In this vital role reporting to the JAPAC Quality team within Clinical & Research Quality (CRQ) the Quality Compliance Manager will lead the implementation of a customized risk-based quality assurance strategy for clinical development programs in Taiwan. You will oversee the full clinical trial lifecyclefrom protocol development to regulatory submissionsensuring quality standards are upheld across all local trials and associated suppliers/vendors. This role requires close collaboration with the Research Quality Leadership Team and key stakeholders in Taiwan to maintain global and regional quality standards. Additionally you will develop deep knowledge of the local market and Amgens clinical strategy while providing quality oversight of critical data and processes for study teams trial sites and vendors operating within the region.

Main Responsibilities:

• Review clinical trial protocols to ensure simplification integration of lessons learned and identification of critical data and processes.

• Provide quality oversight by assessing trial risks using the Risk Assessment Categorization Tool (RACT) ensuring accurate prioritization and mitigation of risks to patient safety data integrity and regulatory complianceincluding country-specific risks relevant to Taiwan.

• Lead the development and implementation of Taiwan-specific Quality Plans establishing local expertise to ensure adherence to applicable regulations.

• Collaborate with Clinical Quality Therapeutic Leads to support TA-specific data integrity including technologies for data collection and measurement (e.g. biomarkers imaging).

• Contribute to the design and execution of TA and affiliate-specific Quality Assurance plans including audit strategies (e.g. investigator site affiliate and study-level audits).

• Support local clinical trial and cross-functional teams in managing quality activities such as issue resolution (e.g. deviations CAPAs serious breaches privacy concerns) inspection readiness and audit/inspection management.

• Monitor analyze and report compliance metrics and trends to key stakeholders and senior leadership providing actionable recommendations.

• Drive innovation by exploring and applying sophisticated quality oversight methodologies including AI Natural Language Processing (NLP) and data analytics.

Win

What we expect of you

Qualifications:

• Bachelors degree in appropriate discipline or equivalent (e.g.: Biomedical Science / Nursing etc.)

• Minimum 5 years in pharmaceutical industry and good in-depth knowledge of ICH GCP standards 2 years or more experience in Quality Management Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.

• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or TrackWise.

• Thorough understanding of Clinical R&D activities and Global/local Regulations. Knowledge of Regulatory Submission and local/Foreign Inspection Management procedures. Quality Oversight of Clinical Trials including clinical trial protocol development execution and submissions.

• Excellent verbal and written communication skills including strong business writing abilities and active listening.

• Ability to transform business and stakeholder feedback into clear efficient processes using a straightforward language and format.

• Strong analytical critical-thinking and decision-making abilities.

• Capability to understand and articulate technical concepts and literature in spoken and written English/Mandarin.

• Travel required (estimated 20%).

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 and move up and across our global organization

• Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.

• Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. 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 a 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 an accommodation.