Quality Leader PDx China job opportunity at GE HealthCare.

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GE HealthCare Quality Leader PDx China
Experience: 5-years
Pattern: full-time
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degreeDiploma
loacation Shanghai, China
loacation Shanghai....China

Job Description Summary This position is responsible for ensuring quality and regulatory compliance of a large and/or multi-modality facility (pharmaceutical, medical device) in PDx China (with potential of supporting Hong Kong and other countries in Asea), while driving process effectiveness and efficiency. He/she represents GE Healthcare Pharmaceutical Diagnostics to external agencies and champions the evolution of the quality culture for the site which includes executing and driving site quality objectives, metrics, reporting and operating mechanisms. 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. Job Description Roles and Responsibilities 1. Accountable for ensuring full quality and regulatory compliance of a facility with regulatory, GE and GDP requirements/regulations, while driving process effectiveness and efficiency at the site. 2. Ensures site audit readiness and hosts the Quality System audits and inspections (internal, customer and regulatory); prepares and executes Quality Management System reviews. 3. Maintains and improves all aspects of Site Quality Planning. 4. Oversees all Quality-related communications and training requirements for all site employees. 5. Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums. 6. Oversees product testing and release procedure for distribution in the region.  Closely works with testing laboratories and external GDP partners. 7. Oversees the Corrective Action / Preventive Action activities and Complaint Handling Programs 8. Reports on Quality System effectiveness and requirements to management team as required including preparing and executing facility Quality Management Reviews. 9. Drives the definition of site quality objectives, metrics, reporting and operating mechanisms. 10. Owns site compliance assessment and remediation plans while influencing site execution, functional policy, local research and development programs, and communications and training requirements for Quality matters. 11. Influences site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines. 12. Influences quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics. 32. If managing a team, provides leadership and facilitates problem resolution, resource utilization, career counseling, mentoring and development of team members. 14. Participates in selected global initiatives to share best practices and leverage quality synergies. 15. Supports local NPI programs and quality issue resolution. 16. Acts as Management Representative for Quality at the Site. 17. Supports audits and oversight of third party suppliers, distribution service providers (warehouses, transport, wholesaler/dealer, channel partners, etc.)  18. Maintains positive relationships-liaisons with customers, local distributors and other business partners. Qualifications/Requirements 1. Bachelor's Degree of Science (Pharmacy, Chemistry, Biology or Biochemistry) 2. Minimum of 5 years working in a regulated pharmaceutical and/or medical device industry. 3. Minimum of 1 year supervisory/management or project leadership experience 4. Ability to communicate effectively in English and Spanish (both written and oral). 5. Demonstrated experience using word processing, spreadsheet, and presentation software. 6. Demonstrated understanding or aptitude to understand Pharmaceutical and Medical Device QMS requirements and regulatory requirements including but not limited to MFDS (Ministry of Food and Drug Safety), FDA CFR 21 820, ISO 13485, Good Distribution Practices (GDP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), China Radioactive Drug Distribution License Application . 7. Hands-on experience with MFDS (Ministry of Food and Drug Safety), FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local or international quality systems requirements. Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required Desired Characteristics 1. Minimum of 5 years supervisory/management experience is preferred. 2. Proven process development and project management skills. 3. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance 4. Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions. 5. Experience in a global, matrixed organization structure. 6. Excellent communication skills (written and oral) 7. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes 8. Demonstrated working knowledge to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, etc. 9. Experience leading, implementing and accelerating change 10. Strong influencing, relationship building, mentoring & networking skills 11. Demonstrated collaboration & conflict resolution skills 12. Proven track record in performing & leading internal and external audits. 13. Exceptional analytical, problem solving & root-cause analysis skills 14.Experience with Quality Control lab process and its demands. 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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support Required Qualifications This role requires advanced experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience). Desired Characteristics strong communication skills 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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Additional Information Relocation Assistance Provided: No

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