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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in GVP auditing, regulatory compliance, and quality assurance within the pharmaceutical industry, with strong leadership and communication skills to guide teams and stakeholders effectively.
Highest-signal resume keywords
GVP Auditing ExperienceKnowledge of EMA, FDA, and ICH GuidelinesQuality Assurance ExpertiseProject Management SkillsAdvanced Leadership Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GVP AuditingQuality SystemsRegulatory Requirements InterpretationPharmacovigilance System Master File ReviewAudit Report PreparationRisk-Based Strategy ImplementationQuality Auditing Topics KnowledgeRegulatory Inspection SupportCompliance Strategy GuidanceTravel Availability
Soft Skills
Excellent Communication SkillsNegotiation SkillsStrategic ThinkingFacilitation SkillsInfluencing Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook
Industry Keywords
Pharmaceutical IndustryQuality AssuranceRegulatory AgencyCompliance Risk ResolutionIndustry Trends Monitoring
About the role
Key responsibilities & impact- Schedule and conduct assigned GVP audits according to the global audit plan
- Prepare audit reports and manage follow-up activities within established timelines
- Maintain expertise in Organon policies, procedures, guidelines, and local/global regulatory requirements pertinent to GVP
- Monitor evolving industry and regulatory trends
- Develop and apply knowledge of Quality auditing topics
- Generate and present comprehensive summaries of audit issues
- Lead initiatives and projects to maintain the effectiveness and efficiency of the audit program
- Support implementation and maintenance of the GVP risk-based strategy
- Assist with development of the annual audit plan and maintenance of the audit tool
- Review and provide input into quality sections of the Pharmacovigilance System Master File (PSMF)
- Support regulatory inspections and external audits
- Train and mentor junior team members
- Provide guidance to internal stakeholders on compliance strategy and compliance-risk resolution and prevention
Requirements
What you’ll need- Minimum of a Bachelor’s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.)
- Fluency in written and spoken English; additional language skills a plus
- Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance
- Minimum of one (1) year of experience in GVP auditing with EU/FDA/global regulatory requirements
- Strong knowledge of EMA, FDA and ICH guidelines in GVP
- Proficiency in interpreting and applying regulatory requirements and guidelines
- Ability to work independently in a virtual environment
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Excellent communication, negotiation, facilitation, influencing, and strategic thinking skills
- Availability to travel up to 20% of time
- Ability to work in partnership with internal and external stakeholders
- Advanced leadership skills
- Strong verbal and effective writing skills
- Project management, prioritization, and resource-utilization skills
- Decision-making and escalation judgment
- Knowledge of regulatory and business trends
- Ability to satisfy applicable travel and credentialing requirements, including associated vaccination prerequisites
Benefits
Comp & perks- Regular employee status
- No relocation
- Travel requirements and associated credentialing/vaccination prerequisites supported as applicable
- Equal opportunity and inclusive work environment