Senior Manager - QARA China
- GE Healthcare
- Posted 7/26/2017 5:23:33 PM
- Job Function: Quality
- Business Segment: Healthcare Quality
Location(s): China; ShangHai; Shanghai
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
This position is responsible for ensuring quality and regulatory compliance of multiple modalities within the China region. He/she represents GE Healthcare to external agencies and champions the evolution of the quality culture for the region which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
1. Defines the Region’s QARA strategy, ensures alignment with China’s priorities while driving quality and regulatory compliance, execution, and process effectiveness/efficiency
2. Partners closely with the QARA Modality Leaders to deliver seamless support to the region across multiple modalities within the Life Sciences portfolio
3. Mobilizes and motivates the QARA team towards fulfilling the region’s goals. Coaches and develops talent in the region
3. Manages overall metrics, reporting, and operating mechanisms in a manner that fulfills business goals for the region
4. Represent GE Healthcare Life Sciences to external agencies and customers as needed. Maintains positive relationships-liaisons with regulatory agencies to gain regulatory intelligence and help strengthen GEHC Life Sciences as a Quality leader
5. Initiates and drives business initiatives, and/or organization changes in the region to create growth opportunities
6. Has authority to stop production, issue product holds (stop orders), make decisions about budgets and people accountability, release products and sign off on project milestones (i.e. New Product Introduction)
7. Leads integrations/divestitures within the region
1. Bachelor’s degree (or high school diploma/GED)
2. Minimum 5 years Quality Assurance, Regulatory Assurance, or Quality Control experience in the pharmaceutical industry
3. Minimum 3 years supervisory/management experience
4. Demonstrated experience with regulations in the pharmaceutical industry, In-depth knowledge in the applicable regulations (GMP, ISO etc.)
5. Knowledge in qualification, validation processes
6. Hands-on experience with FDA, QSR, ISO, MDD and/or other international quality systems requirements.
7. Experience working with 3rd parties and Supplier Quality Management
8. Ability to communicate effectively in English (both written and oral).
9. Demonstrated experience using word processing, spreadsheet, and presentation software.
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
1. Internal candidate strongly preferred.
2. Experience with Biologics
3. Integration experience
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, and ability to influence/lead direct and indirect (dotted-line) reports.
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, DFR, 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
Locations: China; ShangHai; Shanghai