Global Quality Gxp Manager
hace 3 días
**Global Quality GxP Manager**
When you show proactivity and ambition, we’ll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to make a difference? The choice is yours, and we’ll help you get there. Be better together. Be Bayer.
YOUR TASKS AND RESPONSIBILITIES
- Maintain and coordinate QMS at Global Business Services (GBS).
- Perform implementation of global SOPs to QMS.
- Based on updates, train staff with respective effectiveness check.
- Lead self-inspection program: Audit Schedule, Documentation, CAPA follow up, control and report metrics related to KPIs.
- Oversee documentation lifecycle, promote GxP in GBS, promote coordinated teamwork to achieve Data Integrity Standards, support QAAs preparation and update.
- Monitor the deviation/CAPA system.
- Ensure timely implementation and execution of action plans.
- Lead the compilation, analysis and reporting of Quality Metrics (including but not limited to Management, Review KPIs, Quality Board) to detect signals and anticipate potential non-conformities.
- Maintain key performance indicators as per quality objectives - Identify efficiencies and drive improvements as identified.
- Safeguard all documents and confidential information.
- Perform regular cross meetings between GBS sites to ensure common understanding of QMS.
- Promote continuous improvement by identifying problems.
- Development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.
- Act as approver in documents assigned in LifeDoc and some other quality related documents in paper based as required.
- Ability to take decisions based on risk analysis and act in an independent manner.
**WHO YOU ARE**
- Bachelor's degree in life-sciences (chemistry, chemical engineering, pharmacist or equivalent).
- At least 4 years of experience in Quality Management systems, GxP and Data Integrity Requirements.
- Advanced English level, both written and spoken. Any other language is beneficial.
- Strong knowledge in Statistical Techniques (DOE, SP) FDA, ISO, euMDR auditing requirements.
- Internal Quality Auditor or CQE certification preferred.
- Project Management methodologies or Green Belt certification (Desirable).
- High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point, SAP, Project, Visio).
- Extensive and strong problem solving, root-cause analysis and technical/engineering skills to lead and influence change.
- Strong technical writing skills and attention to detail.
- High learning agility and flexibility to adapt to different projects based on business demand.
- Strong leadership, conflict resolution, negotiation, and communication skills, leveraging those skills across different cultures and functions.
- Proven ability to work under pressure and willingness to international travel.
- Capable of leading cross-functional teams globally.
- Ability to multi-task in a fast-paced work environment and to self-directed, as required.
- Adaptable and able to face the changes in a positive way.
- Proactive and self-motivated person.
- Capacity to handle high-pressure situations.
- Good soft skills and emotional intelligence.
- Ability to meet standards for business and quality.
- Flexibility to assume mew roles or responsibilities as required.
**YOUR APPLICATION**
This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
**Location**:
Spain : Cataluña : Barcelona
**Division**:
Enabling Functions
**Reference Code**:
807940
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