Manager, Compliance Quality Systems Job at Baxter (Cartago)

Quality Compliance Manager

The Quality Compliance Manager will lead the implementation of a customized, ris...

Location

Taiwan , Taipei

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
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

Job Responsibility

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 compliance—including 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

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

Fulltime

Quality and Compliance Manager

This role supports a modern cleanroom facility producing a range of health and w...

Location

United Kingdom , Cheshire

Salary:

50000.00 GBP / Year

D R Newitt Recruitment

Expiration Date

Until further notice

Requirements

Experience in a quality or compliance role within food, supplements, or pharmaceuticals
Strong understanding of relevant audit standards
Working knowledge of GMP and UK/EU regulatory frameworks
Experience managing QMS and implementing process improvements
Confident communicator with strong organisational skills
Detail-focused, influential, and able to work collaboratively

Job Responsibility

Maintain site accreditation and ensure audit readiness
Manage the full audit process, including preparation and follow-up
Oversee the Quality Management System and maintain up-to-date documentation
Stay informed on relevant standards and regulatory requirements
Carry out internal audits and manage corrective and preventive actions
Support additional accreditations and customer-specific requirements
Ensure compliance with bonded warehouse regulations
Deliver training and promote awareness of quality and compliance
Work with production, supply chain, technical teams, and suppliers
Support import/export documentation, complaints, and product artwork approvals

Fulltime

Quality Systems Specialist

The Baxter Healthcare Ltd Compounding Facility in Dublin operates to a Manufactu...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Degree or equivalent experience in Science or related field
post qualification experience of at least 1 years in a GMP environment, ideally in a quality role
experience in dealing with Regulatory Compliance desired
good problem solving and investigation skills would be beneficial
an ability to work in a dynamic, fast-paced and goal driven environment
be dedicated
meticulous in attention to professional standards
good professional standards and demonstrates good attention to detail
ability to work under pressure and meet deadlines
highly motivated self-starter and team worker

Job Responsibility

Ensure the compilation of Quality Management Review process
review and approval of process change controls, SOPs, NCRs and CAPAs
implementation, execution and administration of Change Control System and NCR System
administration of Recall process with the Quality management team
administration/co-ordination of risk assessments
support facility projects including process development and quality improvement initiatives
manage and maintain the Documentation System
manage site archive, storage, retrieval and destruction processes
review and approval of Quality documentation
assist in the collation of information and preparation of reports for Annual Product reviews

What we offer

Pension
Health Insurance
Life Assurance
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Manager/Sr. Manager, Global Compliance and Training

The Manager/Sr. Manager, Compliance and Training, will provide expertise in trai...

Location

United States , Durham, NC

Salary:

125000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry
8+ years of relevant experience in a GMP and GXP environment with at least 3 years of demonstrated experience with the development, maintenance, and training oversight required
General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry
Skilled in determining the state and needs of the learner and defining the end goal of instruction
Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills
Ability to work independently
Excellent computer skills and advanced knowledge of Quality Systems
Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office, including Word and Excel
Veeva experience required
Self-motivator with the ability to follow up on and complete multiple projects simultaneously

Job Responsibility

Develops, leads, and implements training initiatives that are aligned with business strategies
Design, develop and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way
Manages the performance/effectiveness of quality system training programs
Work collaboratively on the GXP integrated digital landscape to support, resolve system technical issues and communicate best practices for electronic quality training systems
Assist in the refinement of system user training and support training delivery
Assist in improving and maintaining Beam’s overall Quality Management System (QMS), including policies and procedures, while keeping them current with emerging and changing regulations
Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables
Contributes to the generation, review, and approval of computer system test scripts
Support site and function audit preparations with respect to system functionality
Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems

Fulltime

Quality Systems Technologist

A new opportunity with an established food manufacturing business looking for a ...

Location

United Kingdom , Cambridgeshire

Salary:

38000.00 - 42000.00 GBP / Year

Zest Food Jobs

Expiration Date

Until further notice

Requirements

Knowledge of BRCGS standards and retailer requirements
Strong organisational skills and excellent attention to detail
Good systems capability with confidence in managing data and digital tools
Ability to influence others and challenge where needed

Job Responsibility

Maintain and improve the site's QMS and document control processes
Coordinate internal audits and drive timely closure of actions
Ensure accurate and compliant operational data capture across the site
Monitor supplier approval status and keep specifications up to date
Support complaint trend reduction through effective action management
Assist with traceability exercises and ensure audit readiness
Provide quality performance reporting and insights
Support food safety & quality culture initiatives across all teams

Quality System Analyst

On behalf of our client, we are looking for a QS Analyst (Training & Document Co...

Location

Switzerland , Le Locle

Salary:

Not provided

Randstad

Expiration Date

February 28, 2026

Requirements

Minimum of 1-2 years' experience in document and promotional materials management using electronic document management systems (Agile or Adaptiv or other PLM system)
Minimum of 1-2 years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device or pharmaceutical industries
Minimum of 1-2 years' experience in a Learning Management System (LMS) and its use to deploy training programs and requirements across the company
Knowledge or experience working in an FDA and/or European regulatory environment
Thorough understanding of GMP (Good Manufacturing Practices)/ISO (International Organization for Standardization) regulations
Written and verbal effective communication skills in English and in French including presentations as assigned
Proficient in Microsoft Office tools - Word, Excel, and PowerPoint
Solid document management skills
Strong communication, organizational, negotiation and interpersonal skills
Autonomous / Conscientious / Rigorous / Analytical Mind / Flexible

Job Responsibility

Manage and maintain the electronic training system (assignment, data entry)
Support the maintenance of the document control system
Manage circulation of documents for approval
Review electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
Maintain revision and approval status of all documents
Maintain appropriate form templates for access
Participate in quality system management
Coordinate classroom training sessions
Support during internal and external audits with the required training records or information
Create documentation & procedures related to its position

Fulltime

Regulatory & Compliance Manager

Location

Egypt , Cairo

Salary:

Not provided

PaxeraHealth

Expiration Date

Until further notice

Requirements

Bachelor’s degree in compliance, regulatory affairs, business administration, or related field
At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry
Strong knowledge of industry regulations, quality standards (ISO), and compliance processes
Experience with obtaining ISO 9001, ISO 27000, ISO 13485, FDA, MDR
Excellent English Language
Excellent organizational, leadership, and communication skills
Ability to manage multiple projects and deadlines in a fast-paced environment

Job Responsibility

Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies
Lead efforts to obtain and maintain certifications (e.g., ISO 9001, ISO 27000, ISO 13485, FDA, MDR, and other relevant quality/compliance standards)
Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement
Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings
Monitor and interpret changes in laws, regulations, and industry standards
advise management on compliance implications
Implement and manage the company’s Quality Management Systems (QMS)
Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks
Conduct regular internal audits and assessments to evaluate compliance and certification readiness
Drive continuous improvement in quality processes through monitoring, feedback, and corrective action

Fulltime

Factory Technical Compliance Manager

A fantastic to join a successful and growing food manufacturer as they strengthe...

Location

United Kingdom , Bedfordshire

Salary:

45000.00 - 55000.00 GBP / Year

Zest Food Jobs

Expiration Date

Until further notice

Requirements

Experience in Technical Management, Quality, or Compliance within food manufacturing or retail
Strong working knowledge of HACCP, food safety systems, and third-party standards
Familiarity with BRC, IFS, and major retailer requirements
Hands-on leadership style with strong factory floor presence
Excellent communicator with strong influencing skills
Strong organisational, planning, and time management capabilities
Competent IT skills and experience producing reports and documentation

Job Responsibility

Lead and manage site-wide Quality & Food Safety Management Systems
Ensure compliance with customer standards, BRC, IFS, and major retailer Codes of Practice
Lead HACCP implementation, validation, and maintenance
Manage internal audit programmes and close out non-conformances on time
Investigate and resolve quality and food safety issues with corrective and preventive actions
Maintain audit-ready systems and documentation at all times
Provide floor-based coaching on GMP and hygiene practices
Lead preparation for customer and third-party audits
Maintain schedules, reports, documentation and traceability systems
Deliver training and embed a strong food safety culture

Fulltime

Manager, Compliance Quality Systems

Baxter

Location:
Costa Rica , Cartago

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 25, 2026

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