Global GxP Quality Manager Why Bayer?
"Health for all and Hunger for none" is our mission at Bayer.
Every day, we are privileged to work on purposeful cutting-edge projects to bring our mission to life.
Join us at Bayer to have a career where you can put your passion into practice and make an impact using Science for a better life.
Within our Global Business Services Quality Management Team, we are looking for a Global GxP Quality Manager.
The Global GxP Quality Manager will implement the Quality Management System for GxP relevant processes at Global Business Services (GBS).
The Quality Manager will be responsible for managing the day-to-day operations of the Quality Management Systems (QMS), metrics and trending reporting for Internal Audits, Management Review, QMR, Change Management, Documentation Lifecycle, Deviations, CAPAs and Training.
In this position, he/she must educate, assist and empower operational GBS teams for their services to comply with the good practice guidelines.
Additionally, the Manager will partner with internal departments to develop and support QMS process improvement implementations that meet business and regulatory requirements and perform global trend analysis for Global Business Services (GBS) Complaint Handling functions.
Your main tasks & responsibilitiesMaintain 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.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 determine 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.Who you areBachelor's degree in life-sciences (chemistry, chemical engineering, pharmacist or equivalent).Minimum of 5 years of experience in Quality Management areas.
Pharma, Medical Device or Food industry background.Experience in Quality Management systems, GxP and Data Integrity Requirements.
Strong knowledge in Statistical Techniques (DOE, SPC).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.Fluent in English mandatory (native or proficient), any other language beneficial.In the exchange we will offer youA flexible hybrid work model, with the option to work within the EU, and 3 months/year outside EU.Career development with wide access to professional development tools & trainings.Competitive salary, Bonus & top performers awards.Annual medical check-up.Meals Subsidy in Office.2 additional annual leave days after 3 years in the company.Life & Accident Insurance.100% salary coverage in the event of medical leave.In-house medical service at Bayer premises open 5 days a week for 8 hours.24-hour psychological, medical, and social care for employees and family.Subsidized sports groups, physiotherapy service, online gym.At Bayer office: fitness room, home packaging and laundry, bicycle parking.YOUR APPLICATION 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.
This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding the world, and improving lives.
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