Quality Project Manager

Oximio; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Oximio is seeking a Quality Project Manager to own quality aspects of major strategic projects, including M&A and integrations. You will drive quality governance, risk assessments and regulatory alignment across acquired or integrated businesses.

Reporting to the Chief Quality Officer, you will coordinate with senior stakeholders, design quality integration plans, and ensure compliant implementation throughout project lifecycles in a global clinical research context.

Qualifications

• Bachelor's degree in Quality, Life Sciences, Pharmaceutical Sciences, or a related field.
• Strong background in Quality and/or Regulatory Affairs within a highly regulated industry.
• Project management experience, ideally managing complex, cross-functional or strategic projects.
• Good working knowledge of GxP and GDP requirements, with knowledge of ISO standards.
• Experience with risk assessments, gap analysis, process evaluation and quality improvement activities.
• Experience working across multiple functions and coordinating stakeholders to deliver complex projects.
• Experience in M&A, business integration, implementation or transformation projects is highly desirable.
• Excellent communication and stakeholder management skills, including confidence working with senior leadership and external stakeholders.
• Good working knowledge of English.

Responsibilities

• Lead and coordinate the quality workstream of major strategic projects, including M&A and business integration activities.
• Conduct quality and regulatory gap assessments to identify differences between Oximio and new or existing operations.
• Develop and coordinate quality integration plans, identifying processes, systems, documentation and controls to be implemented or harmonised.
• Perform and coordinate risk assessments and ensure that quality and regulatory risks are addressed.
• Assess the impact of strategic projects on GxP, GDP, ISO and other applicable requirements.
• Work with senior stakeholders and cross-functional teams to define project objectives, priorities, actions and timelines from a quality perspective.
• Collaborate with Quality, Operations, IT, Legal and other functions to ensure successful project delivery.
• Work directly with stakeholders from acquired companies, partners and external organisations during integration and transformation.
• Support the assessment and implementation of new processes, systems and models as part of major projects.
• Monitor quality-related project activities, identify risks or gaps and ensure actions are followed through to completion.
• Provide clear updates and recommendations to the Chief Quality Officer and senior leadership.
• Take ownership of quality-related projects that require dedicated project management and coordination.
• Provide additional quality support when required, including temporary support for operational quality activities across Oximio.

Skills

Quality & Regulatory Affairs

Project management

Stakeholder management

English proficiency

Education

Bachelor's in Quality/Life Sciences/Pharmaceuticals

Job description

Travel: Flexible and occasional travel required, including short-notice travel when project needs arise

At Oximio, we help accelerate clinical research by delivering reliable clinical trial logistics solutions across the globe.

We are looking for a Quality Project Manager to take ownership of the quality aspects of major strategic and business projects across Oximio.

This is a newly established role created to provide dedicated project management support for complex initiatives such as M&A, company integrations, major implementations and other strategic projects. The role will ensure that quality and regulatory requirements are identified, assessed and successfully integrated throughout the project lifecycle.

Working closely with the Chief Quality Officer, CEO and senior stakeholders, you will coordinate quality-related activities across Oximio and newly acquired or integrated businesses, helping turn strategic decisions into practical and compliant implementation plans.

Reporting to the Chief Quality Officer, you will:

• Lead and coordinate the quality workstream of major strategic projects, including M&A and business integration activities.
  
• Conduct quality and regulatory gap assessments to identify differences between Oximio and new or existing business operations.
  
• Develop and coordinate quality integration plans, identifying processes, systems, documentation and controls that need to be implemented, changed or harmonised.
  
• Perform and coordinate risk assessments and ensure that quality and regulatory risks are identified, documented and appropriately addressed.
  
• Assess the impact of strategic projects on GxP, GDP, ISO and other applicable quality and regulatory requirements.
  
• Work with senior stakeholders and cross-functional teams to define project objectives, priorities, actions and timelines from a quality perspective.
  
• Collaborate with Quality, Operations, IT, Legal and other business functions to ensure successful project delivery.
  
• Work directly with stakeholders from acquired companies, partners and other external organisations during integration and transformation activities.
  
• Support the assessment and implementation of new processes, systems and operational models as part of major projects.
  
• Monitor quality-related project activities, identify risks or gaps and ensure that agreed actions are followed through to completion.
  
• Provide clear updates and recommendations to the Chief Quality Officer and senior leadership team.
  
• Take ownership of quality-related projects that require dedicated project management and coordination.
  
• Provide additional quality support when required, including temporary support for operational Quality activities across Oximio.
  

Requirements

• Bachelor's degree in Quality, Life Sciences, Pharmaceutical Sciences, or a related field.
  
• Strong professional background in Quality and/or Regulatory Affairs within a highly regulated industry.
  
• Project management experience, ideally managing complex, cross-functional or strategic projects.
  
• Good working knowledge of GxP and GDP requirements, with knowledge of relevant ISO standards.
  
• Experience with risk assessments, gap analysis, process evaluation and quality improvement activities.
  
• Experience working across multiple functions and coordinating stakeholders to deliver complex projects.
  
• Experience in M&A, business integration, implementation or transformation projects is highly desirable. Direct experience leading an acquisition is not required.
  
• Excellent communication and stakeholder management skills, including confidence working with senior leadership and external stakeholders.
  
• Good working knowledge of English.
  
• Join a growing international company supporting clinical research worldwide.
  
• Take ownership of high-impact projects directly connected to Oximio's growth and strategic development.
  
• Gain exposure to M&A, business integration, transformation and strategic project management.
  
• Opportunity to shape a newly established role and develop the quality project management function at Oximio.
  
• Professional development opportunities in an international and purpose-driven environment.