Provide successful strategic and managerial leadership for the site / supplier in all quality related matters and ensure that key aspects of the operational business comply with cGxP. Provide guidance, support and leadership to teams within area of responsibility.

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

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Quality Control (Qc) Testing

Continued Learning

Technological Intelligence

Employee Performance Evaluations

Quality Standards

Dealing With Ambiguity

Qa (Quality Assurance)

Gmp Procedures

Technological Expertise

People Management

Self-Awareness