Major accountabilities:

Operational

• Collaboration in GxP audits/inspections
• Oversight and implementation of Quality Management System
• Incident management
• GxP Audit and inspection management
• Site Regulatory oversight (incl. Reg-CMC facilitation)
• Exception management
• Supplier Quality management (local)
• Qualification and validation
• Quality Compliance
• Support the QA operation team and product release during project phase
• Responsible for deviation handling
• Responsible for Change Control management
• Responsible for system improving

Leadership & Culture

• Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements and supports a robust career path deployment and succession plan for area of responsibility
• Invest time in personally developing and coaching talents
• Actively support and promote talent exchange for the benefit of the individuals and organization
• Ensure the consistency between career development processes and the business strategy
• Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates
• Ensure that associates are qualified for a GMP task prior to independent performance
• Monitor overall training compliance for in-scope associates
• Identify and maintain a list of subject matter experts for in-scope areas of expertise
• Create a work environment that enables high employee engagement

• Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey

HSE

• Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site
• Ensure overall inspection readiness for area of responsibility.
• Guarantee the effectiveness of the Business Continuity Plan within area of responsibility
• Responsible for participating in initial training and retraining
• HSE incidents reporting & action follow-up

Key Performance Indicators 

• Successful oversight and implementation of Quality Management System
• Carry out improvements in GMP compliance
• Exception and Incident management

Relevant Experience

• Several years of experience (> 3 years) in the field of GMP production or QA or QC Professional experience from official and / or customer audits Expertise in GMP (sterile/non-sterile)
• Functional Breadth; People Leadership; Organization Scope; Scale and Complexity; Collaborating across boundaries; Project Management

Education & Qualification

• University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

Languages

Fluent (oral and written) in English; good in local language (oral and written)

Competencies

• Collaboration; result-oriented; problem-solving-oriented
• Advanced communication skills; motivates colleagues and co-workers
• Maintains exchange of experience
• Leadership and change management, objective setting and performance management
• Budget management, Operational Excellence, Risk Management
• Project Excellence; Stakeholder Engagement; Organizational Savvy; Applied Business Insights
• Additional qualification in the GMP area
• Quality Assurance; Knowledge of GxP, Health Authorities, Supplier Relationship Management; Strategic thinking and planning; Quality decision making; Interdepartmental collaboration; Communication skills; Problem-solving-oriented; Goal-oriented
• MS Office applications and other standard IT applications supporting Quality activities