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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality and Regulatory Affairs, with a strong focus on GxP, GDP, and ISO standards. Proven ability to lead complex projects, coordinate cross-functional teams, and effectively communicate with senior stakeholders.
Highest-signal resume keywords
Quality ManagementRegulatory AffairsProject ManagementGxP KnowledgeStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Integration PlanningRisk AssessmentGap AnalysisProcess EvaluationQuality ImprovementM&A IntegrationBusiness TransformationDocumentation ControlRegulatory Gap AssessmentISO Standards Knowledge
Soft Skills
Excellent CommunicationStakeholder CoordinationLeadership Skills
Industry Keywords
Life SciencesPharmaceutical SciencesHighly Regulated IndustryQuality AssuranceOperational Quality
About the role
Key responsibilities & impact- 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
What you’ll need- 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.
Benefits
Comp & perks- 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.