External Manufacturing Quality Manager 

     

YOUR TASKS AND RESPONSIBILITIES:

 

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 servicesBe responsible for Q assessment of CMO selection, qualification and phase-out according to Bayer standardsAct as Quality representative in front of main External Manufacturing(EM) stakeholders (Procurement, Operations, Technical, Supply) within the Leadership Teams. Ensure on time communication to Country Quality DivisionsMonitoring deviation, complaint and  Out-of Specification(OOS) properly investigated at CMO site including root cause analysisBe accountable for determination and implementation of Corrective and Preventive Actions(CAPA)  and effectiveness checks ensuring continuous improvement of Bayer product and processEvaluate, from a Quality standpoint, change controls at CMOs related to existing portfolio, Transfers and Projects Monitoring and Evaluation of PQRsPerform regular update of Quality Agreements established with CMOsReview and approve analytical validation protocols and reports, generated by third parties Support manufacturing / packaging process of existing and /or transferred/ new products manufactured at CMOsReview 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 BayerCollaborate with technical team to complete transfer activities at CMO site in an efficient and complaint mannerProvide Q inputs for product Innovation and Development, enabling New Product Development project (NPDs) launch in timeAssess and approve quotations related to Projects and NPD quality activitiesMonitor stability study of Bayer products to ensure it performed properly at EM site or 3rd party servicer accordingly to approved stability protocolsContribute during regular internal preparations for planned audits at CMO, to ensure that Audit and Inspections CAPA are properly and timely implementedReview and approval of related Risk Assessments and control strategies. Establish risk mitigation plan in high risk CMO to prevent supplying interruption or critical quality issue

 

 

WHO YOU ARE:

 

Bachelor degree or aboveAt least 5 years quality management experience or audit experience, CMO Q management experience are preferredAt least 8 years of experience in pharmaceutical / life science industry preferably in OTC industry Knowledge in local regulation and GMP requirement of OTC products, food supplement product, Cosmetics and all other relevant quality assurance guidelinesFamiliar with pharmaceutical site operation, include PTC, deviation, change control, and documents etc.Proficiency in both English(TOEIC 730 or above) and Japanese(Native level), written and verbal, with ability to communicate to different audiencesAgile learner with ability to anticipate needs and be pro-activeCross-functional team Player with excellent communication and negotiation skills for international interactionsDemonstrate workload prioritization and time managementStrong flexibility to adapt to different business culturesAbility to travel up to 30% of timeStrong analytical and problem-solving skills

 

 

WHAT BAYER CAN OFFER YOU:

 

We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at BayerWe provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your managerWe support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participationsAt Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employeesWe provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance

 

 

 

 

 

  Date of Employment:1/Jan/2025   Division:Consumer Health  Location:Osaka or Tokyo   Functional Area:Quality  Position Grade:VS 1.2   Employment Type:Regular Work Time:09:00 - 17:30   Contact Us E-Mail  

recruiter_jp@bayer.com