Quality Assurance Manager, PDx Asia
Quality Assurance Manager, PDx Asia
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Job Description
Job Description Summary
The QA Manager is responsible for ensuring GE Healthcare PDxs regional quality and regulatory compliance across Asia including China Hong Kong Taiwan Korea Japan and all associated wholesalers and distributors. This role focuses on maintaining high standards of product quality and regulatory adherence while driving process efficiency and effectiveness.The QA Manager serves as the primary quality representative to external agencies and partners and plays a key role in fostering and advancing a strong quality culture throughout the region.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
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Job Description
Key responsibilities include:
- DirectingtheSiteQualityManagementSystemfullyintegratedintotheGEGlobalQuality ManagementSystemincludingcross-functional 3rd party partners andcountry-specificprocesses.
- Theroleis the responsible for regional compliance covering voluntary regulatory and company qualityrequirements andwillchampion qualityinitiativesatall levelsoftheorganization in the region.
- Maintaining and improvingallaspectsof Quality Planning.
- Overseeingall Quality-related communicationsand training requirementsforallemployees.
- Establishingpositiverelationships with outside agencies.
- Ensuring audit & inspection readiness of all sites in the region.
- Overseeing the Deviations/Investigations CorrectiveAction/ Preventive Action activities and Complaint Handling Programs.
- Report on Quality System effectiveness and requirements to management team as required including compliance of 3rd party GDP partners in the region.
- Drivingthedefinitionofsitequalityobjectivesmetricsreportingandoperating mechanisms.
- Accountable for each of the metrics for the business (i.e. complaint internal audit score employee engagement etc.) and management review process
- Participating inselected globalinitiativesto share best practices and leverage quality synergies.
- Acting as Management Representative for Quality at the Region.
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual Good Distribution Practices Pharmacovigilance (PV) Quality Management System Quality Management Policy Quality Goals and applicable laws and regulations as they apply to this job type/position. Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required. Maintain full Quality System Regulations and Current Good Manufacturing Practices Requirements ensuring compliance to regulations and legal requirements through successful and effective quality management systems. Identify and ensure timely closure of corrective and preventive actions for the site. Participate and represent the Site in external Audits. Mentor and coach direct reports to successful understanding and implementation of Quality System Requirements. Timely communication of all quality concerns initiatives and information to the site Management team. Meet specific quality metrics and/or milestones as defined in annual business objectives. Operates a Local Inspection program and manages follow up activities to close Nonconformities.
Qualifications:
BachelorsdegreeinScientificField(e.g. pharmaceutical chemical engineer chemistry bio-medical science food science and other relevant fields) Understandingofproductdevelopmentmanufacturingqualitycontroland servicinginamedicalequipmentenvironment. Minimum5yearsprofessionalexperienceandunderstandingofproductdevelopmentmanufacturing quality control and servicing in themedicalequipmentor pharmaceutical industry. Minimum 3 years supervisory/ management experience including hiring training coaching and performance management activities. Hands-on experience with FDA QSR ISO MDD and/or other international quality systems requirements. Proven trackrecordinperformingexternalandinternalaudits. Abilityto readanalyzeandinterpretbusinessplanstechnicalproceduresandgovernmental regulations. Effectivereportbusinesscorrespondenceand procedure writingskills. Goodproblemidentificationmultivariable analysisandcreative resolution aptitude. Proven processdevelopmentandprojectmanagementskills. Strong computerskills. Ability to communicate using English
Preferred Qualifications:
Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions. Experienceinaglobalmatrixedorganization structure. Professionalcertification as aGDP or PV Lead Auditor. Six Sigmatraining and/orcertification Team player with aglobalmindset. StrongChangeAcceleration skills. ExperienceinbuildingaQualitySystem fromground up.
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
Required Experience:
Manager
Employment Type
Full-Time
