Manager Quality Compliance & Release Job at Danaher Corporation (Hoegaarden)

Quality Manager

We are seeking a US Quality Manager to work in collaboration with our UK Quality...

Location

United States , Boston

Salary:

109000.00 - 140000.00 USD / Year

PA Consulting

Expiration Date

Until further notice

Requirements

Competent Quality practitioner
Proven experience in operational quality assurance within a regulated environment
Strong working understanding of ISO13485, ISO9001 is a plus
Strong communication skills
Great leadership skills to help inspire staff and coach where needed
The ability to develop, learn and apply Quality principles, best practice, and applicable regulations across multiple disciplines and industry sectors

Job Responsibility

Act as the champion for Quality for PA in the US and globally, with a focus on Design, Engineering and Science
Front external audits from ISO certification bodies for the QMS and from clients undertaking supplier approval audits for work
Be a point of contact to maintain the QMS, provide leadership and engage and help empower staff to take ownership of best practice and codify it in the QMS
Support usage and deployment of the eQMS system to drive change in the business that supports staff and improves compliance
Drive positive change through the organization to improve working practices, and the QMS itself
Develop and deliver the internal audit plan with stakeholders and undertake audits to assess effectiveness of both work and QMS, managing the CAPA process
Develop quality metrics and assess performance against and report findings
Conduct management review meetings and author the summary reports to assess effectiveness of the business and help develop the strategy and long-term plans
Train staff on QMS processes and develop innovative ways to train and engage staff to improve fluency to meet PA's Quality goals and improve the overall culture of Quality
Support client projects, specifically in regulated industries, ensuring activities meet relevant Quality standards / design controls for regulated development

What we offer

Group medical insurance
Health Savings Account with company match
Teladoc and informed nurse line resources
Long term care plan
Group dental insurance
Vision plan
401(k) Savings plan with company profit sharing contribution
Commuter and Parking tax-savings benefit
15 days paid vacation with the opportunity to buy five additional days
10 paid holiday days plus 10 paid sick days

Fulltime

Qp & Quality Manager Compounding

This is where your work makes a difference. At Baxter, we believe every person d...

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use
Act as a Qualified Person (QP) responsible for implementing the quality management system
Lead all aspects of the compounded products release process
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and any potential compounding product quality issues
Develop and maintain an internal review process to ensure continuous compliance
Lead and manage the audit process for the facility
Measure and analyze site quality metrics and indicators
Develop and implement risk management strategies
Coordinate the management, execution, and approval of quality documents and records

What we offer

Pension
Competitive package
Health Insurance
Life Assurance and much more

Fulltime

Qp & Quality Manager Compounding

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

Location

Ireland , Dublin

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

6-10 years’ experience of Quality implementation in Pharma industry
Proven knowledge or experience in applicable regulations and standards e.g. EU GMP Annex 1 particularly in relation to aseptic manufacturing environments
Proven aseptic manufacture experience with knowledge in Sterility assurance and risk management
Proven leadership experience with a track record of consistently meeting results
Ability to operate effectively in a fast-paced environment and prioritize multiple tasks
Proven ability to manage/supervise a large and diverse team of employees
Strong leadership skills to motivate teams, make decisions and guide the organization toward quality objective
Excellent organizational skills for managing tasks, coordinating resources, and ensuring prompt quality data driven decision making
Excellent communication and interpersonal skills to build relationships with collaborators and facilitate collaboration with other Compounding functions

Job Responsibility

Ensure the compounding site follows Good Manufacturing Practice for Medicinal Products for Human Use according to Eudralex Volume 4 and Commission Directive 2003/94/EEC
Act as a Qualified Person (QP) responsible for implementing the quality management system and lead all aspects of the compounded products release process
Serve as the primary contact with the regulatory agency (HPRA) regarding Manufacturing Licence, GMP inspections, and product quality issues
Develop and maintain an internal review process to ensure continuous compliance
Lead and manage the audit process for the facility
Measure and analyze site quality metrics and implement data-driven actions for continuous improvement
Develop and implement risk management strategies to minimize product and process risks
Coordinate the management, execution, and approval of quality documents and records including Nonconformance investigations, CAPA plans, Change Controls, SOPs, Validation Protocols, and Reports

What we offer

Pension
Competitive package
Health Insurance
Life Assurance and much more
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Release Manager

The Release Manager is responsible for planning, orchestrating, and continuously...

Location

India , Hyderabad

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

10+ years in software engineering, DevOps, build/release, or environment management roles, with several years focused specifically on release management or senior release engineering
Bachelor’s degree in Computer Science, Software Engineering, or related field, or equivalent practical experience
Strong hands-on experience with CI/CD platforms (e.g., Jenkins, Azure DevOps/TFS, GitLab CI, TeamCity, Bamboo, GitLab Ultimate Spinnaker, LaunchDarkly) including pipeline design, templates, and shared libraries
Deep understanding of source control systems and workflows (Git, branching strategies such as GitFlow/Trunk based, code review policies, pull requests)
Solid scripting skills (e.g., Bash, PowerShell, Python, Groovy, YAML pipelines) to automate build, deployment, and environment tasks
Experience deploying applications to modern platforms such as Kubernetes, Docker, cloud PaaS (Azure, AWS, GCP), and traditional app servers (Tomcat, IIS, WebLogic, etc.)
Familiarity with configuration management and infrastructure as code tools (e.g., Ansible, Terraform, Puppet, Chef) for repeatable environment provisioning
Good understanding of SDLC, Agile/DevOps practices, and test automation integration in the pipeline (unit, integration, UI, performance, security tests)
Experience with monitoring, logging, and alerting tools to validate releases and rapidly detect issues after deployment
Exposure to ITIL change and release management processes, especially in regulated or enterprise environments

Job Responsibility

Own the release lifecycle from planning to post-implementation review, covering build, deployment, verification, and rollback processes across all environments (dev, test, UAT, pre prod, prod)
Define and manage a release calendar, aligning with product roadmaps, change windows, regulatory constraints, and dependent programs
Coordinate cross functional stakeholders (Product, Development, QA, Security, Ops, Business Owners) to agree scope, cut off dates, readiness criteria, and go/no go decisions
Design, implement, and maintain CI/CD pipelines and build/release automation (e.g., Jenkins, Azure DevOps, GitLab CI, TeamCity), including automated build, test, and deployment steps
Improve and standardize build and deployment processes, reducing manual steps, cycle time, and failure rates through scripting and tooling
Ensure all releases meet defined entry/exit criteria (code freeze, test completion, defect thresholds, security checks, approvals, documentation)
Manage non-production environments (integration, QA, performance, UAT) for release readiness: configuration, data refreshes, scheduling, and conflict resolution between streams
Maintain and enforce branching, versioning, and tagging strategies in source control (e.g., Git, Perforce), including merge policies and baseline management
Troubleshoot and resolve build and deployment issues, working closely with engineering and infrastructure teams
provide on call or out of hours support during critical releases

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan

Fulltime

Senior Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
The ability to manage and supervise a team of employees
Proven leadership skills with the ability to effectively manage, engage and develop teams
Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
Strong change leadership capabilities and experience supporting enterprise-level initiatives

Job Responsibility

Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
Serve as a primary quality microbiology liaison during regulatory inspections
lead preparation activities and develop effective, timely responses to regulatory observations
Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
promote a strong safety culture

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Sr Manager, Quality - Microbiology

At Baxter Healthcare Corporation, we are deeply committed to improving patient o...

Location

United States , Cleveland

Salary:

136000.00 - 170000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework. A graduate degree in Microbiology or related field is desirable
A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience
In-depth knowledge of pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards
Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions
The ability to manage and supervise a team of employees
Proven leadership skills with the ability to effectively manage, engage and develop teams
Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas
Strong change leadership capabilities and experience supporting enterprise-level initiatives

Job Responsibility

Provide overall direction and leadership for microbiology laboratory operations to ensure results consistently meet product quality, safety, and performance standards
Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements
Ensure full compliance with applicable regulations in the including FDA, USP and cGMP requirements within the microbiology laboratory
Serve as a primary quality microbiology liaison during regulatory inspections
lead preparation activities and develop effective, timely responses to regulatory observations
Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans
Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability, efficiency and cost effectiveness
Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards
Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements
promote a strong safety culture

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Site Quality Manager

Our client, a global Leader in Energy sector is looking for further support. The...

Location

Austria , Bruck An Der Leitha

Salary:

4000.00 - 6000.00 EUR / Month ▼

Randstad

Expiration Date

July 10, 2026

Requirements

Completed technical education (e.g. HTL, master craftsman qualification or equivalent) in mechanical engineering, metal engineering, or materials engineering and at least 5 years of expierence
Welding technology, i.e. International Welding Engineer/ Technician, or Certified Welding Inspector (CWI 3.2)
Non-destructive testing methods Level 2 (ISO 9712, ASNT-TC-1A), i.e. VT, PT/MT, RI etc.
Good English speaking and writing

Job Responsibility

Implementation of the Quality Management System on site
Reporting on QA / QC activities to the General Site Manager
Coordination with consortium members at the project site with respect to QA/QC
Cooperation with third party organizations in acceptance testing (e.g. pressure test)
Monitoring and advising sub-contractors and consortium members for compliance with quality management systems requirements as per released field quality plans and procedures
Monitoring performance of weld inspections and nondestructive examinations corresponding with released project specific field quality plans
Support in administration of Corrective Action Reports (CAR) and Non Conformance Reports (NCR)
Performing Welder Skill Test based on requirements
Supporting, coordinating and driving compilation of technical site documentation
Coordinating and monitoring document controlling and its filing within subcontractor system

What we offer

Full-time position with flexible working hours
Company childcare, company doctor, and comprehensive social benefits
Professional development and training opportunities
Experience working in an international team
Attractive salary starting from €56,000 gross / year

Fulltime

Quality Manager

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

Bachelor’s degree experience in science, Engineering, or equivalent
5–8+ years of Quality Assurance experience in regulated manufacturing environments (medical devices, pharmaceuticals, or solutions)
Hands-on experience with QA on the floor, batch release, deviations, investigations, CAPA, and complaints
Strong understanding of applicable quality systems and legal standards
Experience supporting audits and compliance reviews
Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, or combination products
Prior site-level Quality leadership experience in manufacturing environments
Exposure to continuous improvement or operational quality initiatives

Job Responsibility

Provide a strong QA presence on the manufacturing floor
Support real-time quality decision-making during manufacturing
Act as the primary Quality partner concern point for shop-floor issues
Own or supervise batch record review, disposition, and product release activities
Make independent, risk-based batch release decisions
Ensure timely batch release while balancing supply continuity and compliance requirements
Lead and handle nonconformances, deviations, and quality events
Drive high-quality root cause analysis and ensure corrective and preventive actions are appropriate
Ensure CAPAs address systemic issues
Lead or offer QA supervision of manufacturing and quality investigations

What we offer

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

Fulltime

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Manager Quality Compliance & Release

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