Sr QM EM Americas

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

Sr QM EM Americas

Purpose:

• Ensure Readiness of Bayer Global Third-Party Manufacturers including performance monitoring providing quality oversight and assuring compliance and implementation of cGMP and other relevant quality regulations at these sites.

• Accountable for Quality oversight and Product/Process capability on all Bayer formulations manufactured at the Global CMOs within scope of responsibilities.

• Participate and contribute into CMO Lifecycle (Selection, Qualification and Phase-out)
• Support strategy deployment and business needs contributing, as Q EM representative, to relevant decision board.

• Ensure Processes and standards are followed within Quality External Manufacturing in order to better support business needs with regards to suppliers and products from a QA standpoint.

• Steer the Supplier and Product Evaluation Management processes for QM EM Managed Global suppliers from a Quality perspective.

• Participate in Operational Excellence and Product Supply system initiatives and tools with the objective to continuous improvement.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Sr QM EM Americas, are to:

• Assure and monitor the supplier and Bayer products quality and compliance vs current regulations in force and Bayer standards to assure the supply of finished goods and services;
• Ensure Supplier and Product Monitoring and Management from QA point of view by establishing and maintaining Performance Dialogues with suppliers including supplier evaluation and CMO / product / processes risk assessments;
• Act as Quality representative in front of main EM stakeholders (Procurement, Operations, Technical, Supply) within the Leadership Teams;
• Review and evaluation, approval of Deviations and Out of Specifications including root cause analysis.
• Be accountable for determination and implementation of CAPA and effectiveness checks ensuring continuous improvement of Bayer product and process;
• Evaluate, from a Quality standpoint, change controls at CMOs related to existing portfolio, Transfers and Projects;
• Monitoring and Evaluation of PQRs;
• Ensure on time communication to Country Quality Divisions;
• Regular update of Quality Agreements established with CMOs;
• Review and approve analytical validation protocols and reports, generated by third parties Support manufacturing / packaging process of existing and /or transferred/ new products manufactured at CMOs;
• Review process validation protocols and reports in collaboration with Bayer Technical Management functions by ensuring continuous Process Verification and Statistical Process controls run according to relevant Bayer and Health Authorities guidelines and that are properly reported by CMOs to Bayer;
• Ensure within area of expertise, proper follow up and timely completion of transfer activities at CMOs.
• Where applicable liaise with Innovation and Development for activities under responsibilities in New Product Developments (NPDs); Assess and approve quotations related to Projects and NPD quality activities;
• Review and approve Stability protocols and reports; Align on Stability strategies applied at CMOs to demonstrate Product Quality along shelf life; Accountable to establish and maintain a Quality Risk Management culture at CMOs; Review and approval of related Risk Assessments and control strategies;
• Where applicable Contribute to the selection, qualification, and phase-out of CMOs according to Bayer standards;
• Contribute during regular internal preparations for planned audits at CMO, to ensure that Audit and Inspections CAPA are properly and timely implemented;
• Contribute to PQSC and Critical Issues investigations / CAPA implementation and review of CMO Complaint trending review together with Complaint Managers;
• Provide regular training of suppliers in Bayer related requirements;
• Collaborate with Q EM Head on strategy definition to ensure deployment execution within Quality EM Accountable and responsible for timely accomplishment of assigned strategic initiatives and projects;
• Where applicable, liaise and assure coordination of actions with affiliate entities according to the business requirements;
• For triangulated products: Act as delegate of the Responsible Person ("Fachtechnische Verantwortliche Person (FvP)") of BCC AG according to SOP-A1.020. As such, ensure that relevant BCC procedures are considered for the Quality and Compliance related tasks pertaining to the position.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Minimum BS in life science or Pharmacy or related degree;
• Experience in international quality management as well as sound knowledge of international and regional cGMP-, Dietary supplements, Cosmetics, Medical devices, etc., and all other relevant quality assurance guidelines;
• Proficiency in English, written and verbal, with ability to communicate to different audiences; Spanish knowledge are beneficial;
• Readiness in working within innovation and digitalized environment;
• Agile learner with ability to anticipate needs and be pro-active;
• Cross-functional team Player with excellent communication and negotiation skills for international interactions;
• Demonstrate workload prioritization and time management; Strong flexibility to adapt to different business cultures; Experience working with External Manufacturers;
• Ability to travel up to 20% of time;
• Strong analytical and problem-solving skills, dare to try, creative mindset, strategic enabler, collaborative;

Preferred Qualifications:

• Minimum BS in life science or Pharmacy or related degree with 10 years of experience in Quality, Operations or External Manufacturing in pharmaceutical / life science industry;

• Lean six sigma or Operational excellence certificate is a plus;

• GMP Auditing experience is a plus/preferable.