Quality Compliance Job at Baxter (Mountain Home)

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Quality & Compliance Officer

We're recruiting a Quality & Compliance Coordinator on behalf of a growing manuf...

Location

United Kingdom , Hailsham

Salary:

35000.00 - 40000.00 GBP / Month

Office Angels

Expiration Date

Until further notice

Requirements

Must have full valid driving license due to the nature of the role
experience in quality, compliance, or process coordination (manufacturing preferred)
maintaining quality/compliance systems (QMS)
managing BRCGS, FSC & ISO Certifications
strong organisational, analytical, and communication skills
proficient in MS Office, including Excel and Word
flexible, proactive, and able to work independently

Job Responsibility

Support management systems and audit processes
assist with risk assessments and non-conformance management
collate, record, and report operational and compliance data
train and guide teams on procedures and standards
maintain documentation and ensure effective communication with management

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 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

Food Quality Compliance Specialist

The Quality Specialist will support both business teams and suppliers in the IKE...

Location

United States , King of Prussia

Salary:

Not provided

IKEA

Expiration Date

Until further notice

Requirements

Background in food quality assurance, engineering, risk management, and production development
preferably having a food quality assurance or engineering education (2-5 years of working experience within the food industry)
Auditing experience and skills
Certification and practical knowledge of HACCP and HARPC analyses, able to identify gaps
Knowledge of Quality Management Systems and Quality tools
Are result oriented, high energy, and self-driven
Able to assess manufacturing process
Fluent in English (both written and verbal)
Comfortable with traveling up to 50-60% (air travel, domestically and internationally)
Able to drive and hold a valid driver’s license

Job Responsibility

Plan and perform food related audits and verifications and execute assessments according to IKEA standards working instructions
Support the business teams and suppliers in implementing the containment and corrective actions
Coach, inspire, and enable business teams and suppliers in the IKEA quality standards as well as in utilization of problem-solving tools in the daily work and specifically related to quality deviations to continuously maintain and improve compliance performance and create a compliance culture
Review of importers FDA Foreign Supplier Verification Program (FSVP), hazard analyses, documentation, and procedures in accordance with requirements and legislation
Lead and facilitate effective trainings for both internal and external business partners to develop competence of local, global, and IKEA-specific requirements
Update and maintain all necessary systems where reports and results are registered
Secure supplier & product quality/safety compliance following GFSI standard
Lead and participate in global/local projects related to quality
Collaborate across globe within quality matrix to develop IKEA food safety and quality policies

Fulltime

Quality Specialist – Product Compliance

Undertaken batch review for a variety of Products in Poland that require QP batc...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Experience working in Quality Function within the Pharmaceutical industry
Some experience of key areas of Quality Assurance and Pharmaceutical Quality Management Systems (Complaints, CAPA, Deviation, Change Control)
Basic Knowledge of the Pharmaceutical GxP regulations
Able to foster strong cross-functional relationships
Influence, interpersonal, verbal, and written communication skills
Able to respond positively to, and effectively implement, change
Digitally Savvy
Fluency in both English and Polish to handle communication with healthcare authorities in Poland
A degree or equivalent in a relevant scientific subject is desirable

Job Responsibility

Performing a review of manufacturing records for batches of medicinal products certified by Theramex QP
Batch Review all MIA Products Prior to QP Certification
Establish a close working relationship with the Contract Manufacturers and internal stakeholders (Supply Chain, Regulatory, Medical, Marketing) for assigned products
Investigation and resolution of complaints with CMOs
Determining and implementing robust CAPAs as required
Assessment and approval of deviations
Managing and approval of change controls
Creation and Maintenance of Quality / Technical Agreements
Ensuring CMO’s are supplied and adhere to Compliance Files / Marketing Authorisations
Support of on-site audits and visits

Life sciences quality and compliance engineer

As a Quality & Compliance Engineer, you will ensure that products, processes, sy...

Location

Belgium , Machelen

Salary:

Not provided

Sopra Steria

Expiration Date

Until further notice

Requirements

Graduate with a Master's degree in a scientific direction (Industrial Ir, Bio Ir, Chemie, Biotechnology, Pharmacy,...) or equivalent by experience
Experienced in working in a regulated environment, with developed document writing skills
You demonstrate the consultancy mindset by being pro-active, taking ownership and showing commitment
Problem solving mindset and eager to learn and evolve
You have a strong sense of responsibility and an eye for quality
You will contribute to projects for top companies, both nationally and internationally
Teamplayer with the ability to go in full focus-mode when independent work is required

Job Responsibility

Ensure that products, processes, systems and services in the world of Life Sciences meet regional and global quality regulations and standards
Active in various areas such as computer system validation (CSV), MES, lab qualification, Quality Assurance, Engineering

What we offer

Mobility options (including a company car)
Insurance coverage
Meal vouchers
Eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
Opportunity to connect with fellow Sopra Steria colleagues at various team events

Head of Quality, Regulation & Estates Compliance

Head of Quality, Regulation & Estates Compliance role for a reputable care organ...

Location

United Kingdom , Ashford, Kent

Salary:

65000.00 - 75000.00 GBP / Year

Office Angels

Expiration Date

Until further notice

Requirements

Extensive experience in Quality Assurance within the care sector
Ideally with background as a CQC inspector
Registered General Nurse (RGN) qualification is highly desirable
Proven track record in social care settings with extensive experience in reviewing and auditing
Solid understanding of the Social Care Act 2012, CQC Regulations, and Safeguarding protocols

Job Responsibility

Lead quality assurance activities to ensure homes meet and exceed regulatory expectations
Conduct in-depth audits and design innovative processes for continual improvement
Stay updated on CQC regulations and implement necessary changes across homes
Monitor Estates compliance, ensuring all checks and certifications are correctly filed and maintained
Collaborate with senior management and staff to foster culture of excellence
Deliver training programmes for 500+ staff members
Manage escalated complaints and grievances
Conduct quarterly audits and maintain comprehensive records

What we offer

Electric company car (valued at £7k)
Statutory pension
25 days annual leave
Access to perks through Perk Box
Supportive working environment
Opportunities for professional development and growth

Fulltime

Quality Compliance

Baxter

Location:
United States , Mountain Home

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 06, 2026

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Job Description:

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