Strategic Quality Project Lead (M&A & Integration)

Oximio; United States; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality & Regulatory Affairs

Project management

Stakeholder management

English proficiency

Formation

Bachelor's in Quality/Life Sciences/Pharmaceuticals

Description du poste

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.