GxP Senior Expert/Manager

<p align="justify"> </p> <p align="justify">GxP Senior Expert/Manager </p>           <p>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.</p> <p> </p> <p>YOUR TASKS AND RESPONSIBILITIES</p> <p> </p> <ul> <li>Maintain and coordinate QMS at Global Business Services (GBS).</li> <li>Perform implementation of global SOPs to QMS.</li> <li>Based on updates, train staff with respective effectiveness check.</li> <li>Lead self-inspection program: Audit Schedule, Documentation, CAPA follow up, control and report metrics related to KPIs.</li> <li>Oversee documentation lifecycle, promote GxP in GBS, promote coordinated teamwork to achieve Data Integrity Standards, support QAAs preparation and update.</li> <li>Monitor the deviation/CAPA system.</li> <li>Challenge and review root cause investigations and CAPA plans by applying risk management techniques (xFMEA).</li> <li>Ensure timely implementation and execution of action plans.</li> <li>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.</li> <li>Maintain key performance indicators as per quality objectives - Identify efficiencies and drive improvements as identified.</li> <li>Safeguard all documents and confidential information.</li> <li>Perform regular cross meetings between GBS sites to ensure common understanding of QMS.</li> <li>Promote continuous improvement by identifying problems.</li> <li>Development of projects to determinate the fundamental causes of the problems and definition and implementation of action plans.</li> <li>Act as approver in documents assigned in LifeDoc and some other quality related documents in paper based as required.</li> <li>Ability to take decisions based on risk analysis and act in an independent manner.</li> </ul> <p> </p> <p>WHO YOU ARE</p> <p> </p> <ul> <li>Bachelor's degree in life-sciences (chemistry, chemical engineering, pharmacist or equivalent).</li> <li>At least 3 - 4 years of experience in Quality Management systems, GxP and Data Integrity Requirements.</li> <li>Advanced English level, both written and spoken. Any other language is beneficial.</li> <li>Strong knowledge in Statistical Techniques (DOE, SP) FDA, ISO, euMDR auditing requirements.</li> <li>Internal Quality Auditor or CQE certification preferred.</li> <li>Project Management methodologies or Green Belt certification (Desirable).</li> <li>High-level computer knowledge (Excel, Word, E-mail, Change Control, Power Point, SAP, Project, Visio).</li> <li>Extensive and strong problem solving, root-cause analysis and technical/engineering skills to lead and influence change.</li> <li>Strong technical writing skills and attention to detail.</li> <li>High learning agility and flexibility to adapt to different projects based on business demand.</li> <li>Strong leadership, conflict resolution, negotiation, and communication skills, leveraging those skills across different cultures and functions.</li> <li>Proven ability to work under pressure and willingness to international travel.</li> <li>Capable of leading cross-functional teams globally.</li> <li>Ability to multi-task in a fast-paced work environment and to self-directed, as required.</li> <li>Adaptable and able to face the changes in a positive way.</li> <li>Proactive and self-motivated person.</li> <li>Capacity to handle high-pressure situations.</li> <li>Good soft skills and emotional intelligence.</li> <li>Ability to meet standards for business and quality.</li> <li>Flexibility to assume mew roles or responsibilities as required.</li> </ul> <p> </p> <p> </p>     YOUR APPLICATION       <p>Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.</p> <p>Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. </p> <p>Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.<br/>  </p>           Location: Poland : Pomorsk