Quality Compliance Manager Job at Amgen (Taipei)

Quality Compliance Manager

In this vital role you will report to the Japan Asia Pacific (JAPAC) Quality Com...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's 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
Good knowledge of Regulatory Submission and overall Inspection Management procedures expected by Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Experience in supporting regulatory inspections by overseas authorities (e.g. FDA, EMA), at Sponsor, CRO, or investigator‑site level is preferred
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

Job Responsibility

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
Provide oversight for the development and implementation of Quality Plans specifically suited within Japan
Establish country level expertise to ensure quality and compliance to local regulations and international guidelines (e.g.: ICH GCP, WHO etc.)
Liaise with the Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g.: biomarker usage and imaging methods)
Collaborate on TA and Affiliate-specific Quality Assurance plans for application within the region
Support local Clinical Trial and global/local cross-functional teams for all quality management activities, including Issue Management, Risk Assessment, Inspection Readiness activities, Audits and Inspection Management activities
Prepare, analyze and communicate compliance metrics/trends on a periodic basis to key stakeholders and senior leaderships
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)

Fulltime

GCP Quality Compliance Manager

In this vital role you will provide proactive end to end quality support for the...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong experience in GCP within Clinical R&D, Quality, or Study Management environments
Knowledge of electronic Quality Management Systems (e.g., Veeva, TrackWise) and clinical trial oversight processes
Solid understanding of clinical development, protocol execution, regulatory submissions, and inspection management
Proven ability to support operational and quality oversight of clinical trials from development through submission
Excellent written and verbal communication skills, including business writing and stakeholder engagement
Strong analytical, critical-thinking, and problem-solving capabilities with the ability to simplify complex processes and technical concepts
Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry is preferred
Degree educated

Job Responsibility

Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program, including protocol development, database lock, and regulatory submissions/ approvals
Oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials
Serve as the GCP quality SME, providing independent quality guidance for clinical trial activities aligned with global regulations and best practices
Oversee quality and compliance across all stages of clinical development programs, including risk management through RACT and protection of patient safety, rights, and data integrity
Support clinical trial teams with quality management activities such as deviations/CAPAs, inspection readiness, serious breaches, privacy issues, and regulatory inspection responses
Review protocols and trial processes to drive simplification, apply lessons learned, and identify critical data and operational risks
Implement innovative, risk-based quality oversight approaches using advanced analytics, AI, and NLP methodologies
Monitor and analyze quality metrics and trends, identify gaps, and recommend corrective and preventive actions to stakeholders and senior leadership
Provide vendor quality oversight and support regional compliance with local regulations and regulatory requirements
Plan, conduct, and report risk-based GCP audits, including investigator site, affiliate, and study-level audits

What we offer

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

Senior Manager Quality Compliance External Affairs

The Senior Manager Quality Compliance External Affairs will enhance quality, com...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Minimum of 12-16 years of experience in pharmaceutical manufacturing / quality
Experience in working with and representing a company in external organizations
Ability to interpret, analyze, and communicate information, not simply summarize
To manage / lead multiple programs and/or projects
Understanding of global regulatory Quality requirements (incl. GxP, Supply chain, Medical Device / Combination products, Pharmacopoeia)
Knowledge in Pharmaceutical Quality Systems / Quality Management Systems
Proven ability to understand technical, scientific, and medical information
Involvement in external activities representing a company / agency
Computer and database skills

Job Responsibility

Representing Amgen in industry trade, individual based associations and/or academia
Networking with peers from other companies and regulatory authorities
Taking opportunities to lead teams in and represent for these external professional bodies and organizations
Communicating Amgen’s perspectives and knowledge to regulators, governments, associations, and academia
Support organizing educational site visits of regulatory / governmental officials
Supporting or leading the commenting on regulatory documents incl. pharmacopoeias
National and international travel required (up to 20%)
Networking across various Amgen functions
Answering day-to-day questions on regulatory trends and interpretation of regulatory documents
Providing training / education sessions to enhance the knowledge on regulatory and technical expectations

Fulltime

Manager Quality Compliance & Release

The Manager Quality, Compliance & Release (QCR) is responsible for leading the c...

Location

Belgium , Hoegaarden

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

5 plus years of quality experience, experience (in a manufacturing environment) as a people leader
strong working knowledge of quality assurance principles and practices, industry and international regulations and standards
Fluency in English and Dutch is required (written & spoken)
Ability to travel (international) – 5-10% max
Must have a valid driver's license

Job Responsibility

Managing the Customer Audits
heading Quality Systems related activities
responsible for the local Quality System in our global document management system
responsible for final product release to market
approximately 10% customer audits and 50% Quality Systems activities and 40% product Release activities
keeping oversight of quality compliance activities (internal and external) and managing the metrics and KPI related to this
maintaining the overview of the certified state of products
Quality Lead responsible in plant-wide continuous improvement projects related to QA Compliance and Release

Fulltime

ISO Quality Compliance Manager

We are seeking an experienced and detail-oriented ISO Quality Compliance Manager...

Location

Pakistan , Rawalpindi

Salary:

Not provided

Translation Empire

Expiration Date

Until further notice

Requirements

Deep understanding of ISO standards (e.g., ISO 9001, ISO 27001, ISO 14001)
Extensive experience in auditing, quality management systems (QMS), and regulatory compliance
Experience in [Insert Industry, e.g., Manufacturing, IT, Healthcare, etc.]
Knowledge of other standards like ISO 45001, GDPR compliance, or sector-specific regulations
Experience with risk management and business continuity planning

Job Responsibility

Manage and ensure ongoing compliance with ISO standards (e.g., ISO 9001, ISO 27001, ISO 14001)
Lead and coordinate ISO certification, surveillance, and recertification audits
Develop, implement, and maintain the company’s Quality Management System (QMS) in alignment with ISO and regulatory requirements
Review and update quality policies, procedures, manuals, and process documentation regularly
Plan, organize, and conduct internal and external audits
ensure timely closure of non-conformities
Identify gaps and areas for improvement
lead corrective and preventive action plans (CAPA)
Deliver ISO standards and compliance-related training and awareness programs to employees
Promote a culture of quality, compliance, and continuous improvement across all departments

Fulltime

Manager, Compliance Quality Systems

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Academic background: Quality, Industrial, Chemical, Biomedical or related Engineering
Experience: 10+ years in Quality roles, with at least 5 in leadership positions
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
Technical skills: Process engineering, validations and quality controls
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)
Audit and regulatory compliance management
Proficiency in oral and written English
Leadership proficiencies: Inspiring and focused leadership
Effective communication and collaborator management

Job Responsibility

Quality System Management: Ensure the establishment, maintenance and improvement of a quality system that meets regulatory, normative and corporate requirements
Approve local specifications and procedures as a Quality Representative
Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies
Risk Management and Compliance: Implement strategies to identify, assess, and mitigate quality risks in processes, equipment and materials
To control the accurate administration of the material and human resources required for compliance with processes
Technical and Business Leadership: Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards
Promote improvement, simplification, innovation and consistency to regulatory standards projects
Represent the Director of Quality in their absence and in strategic committees
People Management and Talent Development: Build and complete development and training plans for the members of the department passionate about Quality
Ensure the continuous training and development of the teams responsible for Quality Engineering

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Manager, Compliance Quality Systems

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Quality, Industrial, Chemical, Biomedical or related Engineering
10+ years in Quality roles, with at least 5 in leadership positions
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others)
Process engineering, validations and quality controls
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA)
Audit and regulatory compliance management
Proficiency in oral and written English
Inspiring and focused leadership
Effective communication and collaborator management

Job Responsibility

Quality System Management: Ensure the establishment, maintenance and improvement of a quality system that meets regulatory, normative and corporate requirements
Approve local specifications and procedures as a Quality Representative
Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies
Risk Management and Compliance: Implement strategies to identify, assess, and mitigate quality risks in processes, equipment and materials
To control the accurate administration of the material and human resources required for compliance with processes
Technical and Business Leadership: Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards
Promote improvement, simplification, innovation and consistency to regulatory standards projects
Represent the Director of Quality in their absence and in strategic committees
People Management and Talent Development: Build and complete development and training plans for the members of the department
Ensure the continuous training and development of the teams responsible for Quality Engineering

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Compliance and Quality Manager

Location

United Kingdom , Leeds

Salary:

65000.00 - 70000.00 GBP / Year

Morson Talent

Expiration Date

Until further notice

Requirements

Significant experience in a rail, construction, engineering, or infrastructure environment
Strong working knowledge of ISO 9001, ISO 45001, and ISO 14001
Experience managing RISQS audits and accreditations
Proven experience leading audits and managing corrective actions
Strong understanding of legislative and regulatory compliance
Excellent stakeholder management and communication skills
Lead Auditor qualification
Experience with Network Rail standards and assurance processes
Experience supporting Principal Contractor duties
Familiarity with Sentinel / rail assurance systems

Job Responsibility

Lead and manage all ISO certification activities, including ISO 9001 (Quality), ISO 45001 (Health & Safety), and ISO 14001 (Environmental), ensuring ongoing compliance and successful external certification audits
Act as the primary point of contact for RISQS accreditation, including audit preparation, evidence management, corrective actions, and continuous improvement
Manage and maintain compliance with the Principal Contractor's Licence and associated assurance requirements
Develop, maintain, and deliver a risk based audit programme, including: Internal audits, Supplier audits, System and process audits
Plan, manage, and maintain the annual audit schedule, ensuring audits are completed on time and actions are tracked to closure
Lead the investigation, management, and close out of Non Conformances (NCRs), including root cause analysis and verification of corrective actions
Support continuous improvement through audit findings, trends, and lessons learned
Create, review, and approve Project Quality Management Plans (QMPs) to support safe, compliant project delivery
Provide quality and compliance support to operational teams during project planning and execution
Ensure quality requirements are embedded into project lifecycle processes

Fulltime

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Quality Compliance Manager

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