Manager, Compliance Quality Systems Job at Baxter (Cartago)

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

Quality Systems Manager

Location

United States , Burnsville

Salary:

130000.00 - 165000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/training
10+ years’ experience in Quality Systems
4+ years within the medical device industry
Comprehensive working knowledge of EU MDR, ISO 13485, 21 CFR 820
Experience leading audits, CAPA systems, and regulatory inspections
Proven ability to effectively influence cross-functional teams

Job Responsibility

Owns, maintains, and improves the Quality Management System in compliance with 21 CFR Part 820, EU MDR, ISO 13485, and other applicable international regulations and guidelines
Ensures effective implementation and ongoing compliance with QMS processes, procedures, and records
Owns and maintains electronic QMS system
Manages document control, record retention, and change control processes
Drives harmonization and simplification of quality documentation where possible
Owns and maintains external document and standards database and drive updates, as applicable
Plans, conducts, and manages internal audits and support external regulatory and customer audits
Acts as the primary interface with regulatory authorities and notified bodies during inspections
Leads audit responses, root cause analysis, and corrective actions to closure
Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Plant Quality Systems Manager

Reporting to the Manager Quality, the Manager Quality Systems will be responsibl...

Location

United States , Fort Gibson

Salary:

Not provided

Refresco

Expiration Date

Until further notice

Requirements

Proficient in Excel, Word, SAP and Power Point
Ability to analyze and solve problems, results oriented
Organized and detail-oriented, adaptable to change
Able to read and understand metric system
A bachelor’s degree in quality management or a related technical discipline is strongly preferred
A minimum of 5 years of progressive experience in Quality Assurance or Quality Control within a fast-paced manufacturing environment, preferably in the food or beverage industry
Demonstrated experience in the successful implementation, management, and continuous improvement of Quality System Software
In-depth understanding of Global Food Safety Initiative (GFSI) standards, such as Safe Quality Food (SQF) or FSSC 22000, with hands-on experience managing compliance and audits
Proven experience working with real-time data collection systems to monitor and analyze production processes

Job Responsibility

Adhere to and ensure compliance to all health and safety policies/procedures, Good Manufacturing Practices (GMPs) and adhere to the required personal protective equipment (PPE)
Adhere to and ensure compliance to food quality and food safety guidelines per Refresco, Customer and/or governing bodies (ex. SQF) standards
Responsible for complying with FDA, state/city regulations, Refresco quality policies, GMP's, HACCP, Allergen, Kosher, etc as well as other regulations required
Provides guidance and training on work standards and expected outcomes
Overall plant owner for quality systems which includes document control and quality data collection applications
Responsible for supporting and maintaining compliance with third-party food safety and quality certification requirements, including the implementation and continual improvement of the facility’s food safety and quality management systems
Responsible for the development, implementation, maintenance, and continuous improvement of the SQF System and ensuring compliance with all relevant food safety and quality requirements
Overall plant owner for audit systems which includes internal audits and external audits
Will audit and verify with the local team to ensure quality systems comply per Refresco corporate guidelines
Plant owner for quality project to ensure proper documentation has been completed such as validation and verification protocols

What we offer

Medical/Dental/Vision Insurance
Health Savings Accounts and Flexible Spending Accounts
Life and AD&D Insurance, critical illness, hospital indemnity, and accident insurance
Short-term disability and long-term disability
Pet Insurance
Legal Benefits
401(k) Savings Plan with Company Match
12 Paid Holidays
Vacation Days and Paid Sick Time Off Days
Well-being Benefit

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

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

Quality Systems Manager

The Quality Systems Manager role will support both the Crewe and Aston sites, ty...

Location

United Kingdom , Nantwich

Salary:

Not provided

Bakkavor

Expiration Date

Until further notice

Requirements

Strong knowledge of quality management systems within a fast-paced food manufacturing or FMCG environment
Proven capability managing audits, allergens and risk assessments to high standards
Confidence producing and analysing KPIs to support continuous improvement
Experience managing customer complaints and non-conformance processes
Strong stakeholder engagement skills across technical and operational teams
High attention to detail with a structured and methodical approach
Ability to prioritise, influence and manage multiple activities effectively
A proactive mindset with a passion for quality assurance and service excellence

Job Responsibility

Managing and developing the quality management system, ensuring documentation is controlled, current and compliant with legislation and industry standards
Establishing and maintaining robust audit processes against the QMS to review compliance and drive improvement
Creating and maintaining structured reviews of industry, customer and business codes of practice, presenting action plans and embedding best practice
Managing the internal audit programme, ensuring actions are communicated and closed out within agreed timescales
Collating and communicating food standards agency and customer alerts, responding effectively and in a timely manner
Managing HACCP teams, coordinating and documenting reviews and ensuring updates are implemented across the business
Managing BRC and internal pillar audits, ensuring non-conformances are addressed and closed within agreed timescales
Operating safely and supporting the team to uphold high standards of health, safety and environmental compliance
Supporting site and business-wide continuous improvement initiatives

What we offer

Competitive salary and job-related benefits
Holidays
Competitive matched pension contributions
Life insurance up to 4x salary
Company share save scheme
Greencore Qualifications
Exclusive Greencore employee discount platform
Access to a full Wellbeing Centre platform
Enhanced parental leave and menopause policies

Fulltime

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Manager, Compliance Quality Systems

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