Company
pharmaceutical
QualityComplianceManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Compliance Manager. Skills: Quality Compliance, Quality Oversight, Risk Management, Regulatory Affairs. Provide proactive end to end quality oversight strategies. Develop and implement customized risk-based quality assurance strategy”
Industry & Context.
analytical, critical-thinking, and decision-making abilities
International and Domestic Travel required (estimate 10%)
What They're Looking For.
Must Have
Bachelor’s degree in appropriate discipline or equivalent, Minimum 5 years in pharmaceutical industry, 2 years or more experience in Quality Management, 2 years or more experience in Quality Assurance, 2 years or more experience in 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, experience managing quality in electronic QMS such as Veeva or TrackWise, Thorough understanding of Clinical R &D activities and Global/local Regulations, Good knowledge of Regulatory Submission, Good knowledge of overall Inspection Management procedures expected by Japan Pharmaceuticals and Medical Devices Agency (PMDA), Quality Oversight of Clinical Trials, Excellent verbal and written communication skills, business writing abilities, active listening, analytical, critical-thinking, and decision-making abilities, Business-level Proficiency in English, Business-level Proficiency in Japanese
Nice to Have
Experience in supporting regulatory inspections by overseas authorities (e.g. FDA, EMA), at Sponsor, CRO, or investigator‑site level
What You'll Do.
Provide proactive end to end quality oversight strategies
Develop and implement customized risk-based quality assurance strategy
Manage end to end Quality Oversight for all local trials
Manage all associated suppliers/vendors operating within the country
Implement risk-based quality strategy
Advance quality by design principles
Provide oversight and quality management of critical data and processes
Review specific clinical trial protocols
Ensure simplification of protocols
Apply lessons learned to protocols
Identify critical data and processes
Provide quality oversight for RACT
Assess RACT for each trial
Ensure proper identification of risks
Ensure proper prioritization of risks
Ensure proper mitigation of risks
Mitigate risks to patient safety
Mitigate risks to patient welfare
Mitigate risks to patient rights
Consider country related risks
Provide oversight for Quality Plans development
Implement Quality Plans within Japan
Establish country level expertise
Ensure quality to local regulations
Ensure compliance to local regulations
Ensure quality to international guidelines
Ensure compliance to international guidelines
Liaise with Clinical Quality Therapeutic Leads
Support TA-specific data integrity
Support technologies for data collection
Support technologies for data measurement
Collaborate on TA and Affiliate-specific Quality Assurance plans
Ensure plans are fit for purpose
Ensure plans are risk based
Ensure plans are efficient
Develop TA specific audit plans
Execute investigator site audits
Execute affiliate audits
Execute study level audits
Support local Clinical Trial teams
Support global/local cross-functional teams
Manage quality management activities
Manage Issue Management
Manage Deviations/CAPAs
Manage Serious Breaches/ Privacy Issues
Manage Risk Assessment
Manage Inspection Readiness activities
Manage Inspection Management activities
Prepare compliance metrics/trends
Analyze compliance metrics/trends
Communicate compliance metrics/trends
Provide recommendations
Seek innovative quality oversight methodologies
Implement innovative quality oversight methodologies
Seek proactive quality oversight methodologies
Implement proactive quality oversight methodologies
How You'll Work.
Team & Collaboration
Form a partnership with the Clinical Research Quality Leadership Team; Form a partnership with Global/Regional/Local study teams; Form a partnership with key stakeholders across Japan Development teams; Support local Clinical Trial teams; Support global/local cross-functional teams
Communication Scope
Excellent verbal and written communication skills; business writing abilities; active listening; Ability to transform business and stakeholder feedback into clear, efficient processes; Ability to use straightforward language and format
Full Job Description
## **Career Category** Quality ## ## **Job Description** **WHAT YOU WILL DO** In this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Compliance Director within Clinical & Research Quality (CRQ). The Quality Compliance Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development programs within Japan. The Quality Compliance Lead will manage end to end Quality Oversight for all local trials, and all associated suppliers/vendors operating within the country. The Quality Compliance Lead is responsible for implementing 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). In addition, the Quality Compliance Lead will form a partnership with the Clinical Research Quality Leadership Team, Global/Regional/Local study teams and all key stakeholders across Japan Development teams to ensure that all global and regional quality standards are maintained, and inspection ready. This is a vital role who will develop a deep knowledge of the local market and Amgen’s clinical development strategy. This role also provides oversight and quality management of critical data and processes for local study teams, clinical trial sites, and all associated suppliers/vendors that operate within the country. **RESPONSIBILITIES** * Review specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes * Provide quality oversight and assess the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights. This also includes any country related risks that needs to be considered for clinical trials operatin
Applying for this Quality Compliance Manager role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about this company?
Real rants from real employees. Read before you apply.