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Head of Deviation Management, Change Management – Pharma
TRIGA Consulting GmbH & Co. KGPharmaunternehmen: Leitung von Change Control, Deviation Management und CAPA. Führung eines achtköpfigen Teams sowie Weiterentwicklung internationaler GMP-Qualitätsprozesse.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in Change Control, Deviation Management, and CAPA within the pharmaceutical industry, ensuring compliance with GMP guidelines and effective leadership of cross-functional teams. Proven ability to manage quality processes, implement corrective actions, and communicate effectively with stakeholders in both German and English.
Highest-signal resume keywords
Change Control ManagementDeviation ManagementCAPA ExpertiseRoot Cause AnalysisGMP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Change ControlDeviation ManagementCAPARoot Cause AnalysisQuality Process ManagementRegulatory RequirementsGMP GuidelinesImplementation CapabilityStrategic ManagementTask Allocation
Soft Skills
Leadership SkillsDecision-Making SkillsCommunication SkillsStructured Working StyleSolution-Oriented Approach
Certifications & Qualifications
Master’s Degree in PharmacyMaster’s Degree in ChemistryMaster’s Degree in BiologyMaster’s Degree in Medicine
Industry Keywords
Pharmaceutical IndustryQuality AssuranceRegulatory ComplianceCross-Functional CollaborationInternational Quality Processes
About the role
Key responsibilities & impact- Functional and disciplinary leadership of a team of approximately 8 employees
- Overall responsibility for Change Control, Deviation Management and CAPA
- Ensure GMP-compliant, timely and fully traceable handling of all changes and deviations
- Strategic management of task allocation, priorities and resources
- Central point of contact for escalations and coordination of decision-making and resolution processes
- Management and quality assurance of root cause analyses
- Definition of appropriate corrective and preventive actions (CAPA)
- Monitor implementation of CAPAs and assess their sustained effectiveness
- Ensure complete and regulatorily robust documentation
- Collaboration with internal departments and external partners
- Further development and harmonization of existing quality processes in an international environment
- Identify improvement opportunities and initiate sustainable optimization measures
Requirements
What you’ll need- Master’s degree, preferably in Pharmacy, Chemistry, Biology, Medicine or a related scientific discipline
- At least seven years of relevant professional experience in the pharmaceutical industry
- At least seven years of experience in functional and disciplinary leadership of staff
- Solid expertise in Change Control, Deviation Management and CAPA
- Strong knowledge of root cause analysis and the definition and effectiveness assessment of appropriate measures
- Confident handling of regulatory requirements and GMP guidelines in a pharmaceutical environment
- Experience managing complex, cross-functional quality processes
- Strong decision-making skills and the ability to handle quality-related escalations with confidence
- Strategic, structured and solution-oriented working style with strong implementation capability
- Convincing communication and leadership skills, with a confident manner toward internal and external stakeholders
- Very good proficiency in German and English
Benefits
Comp & perks- A responsible leadership position with high visibility and influence
- A dynamic, growing company with an international working environment
- An attractive compensation package
- Flexible working models with the option to work remotely
- The possibility to work temporarily from another EU country
- Working time account with time-off compensation and 30 days of vacation
- A flexible additional allowance, e.g., for company pension schemes, fitness and health programs, or subsidies for commuting and meal expenses
- Individually tailored internal and external training opportunities
- Access to a corporate benefits platform with discounts from numerous partner companies
- An open, direct corporate culture and regular company and team events