长沙招聘

Business Segment

Healthcare Quality

About Us

GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com

Role Summary/Purpose

The Senior Manager – Quality Operations is responsible for leading the site Quality team (Quality Assurance and Quality Control teams), driving a consistent message about GE Healthcare's Quality vision and plans to execute at the local site and driving the definition of site quality objectives, metrics and reporting and operating mechanisms.

Essential Responsibilities

• Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
• Ensures site audit readiness and hosts the Quality System audits; prepares and executes Quality Management System reviews
• 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)
• Maintains positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
• 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
• Responsible for site education of non-Quality Assurance employees along with professional development of the site Quality Assurance team
• Provide leadership and coaching for the Quality Control team & ensure the timeliness of testing of our products manufactured
• Support & participate in the plant-wide efforts to reduce scrap and rework costs, and to identify root causes and solutions for quality defects
• Ensure the meaningful and timely resolution of Quality records including CAPA's, PSR's, and PQR's
• Coach the Quality teams on the tools and practices required to drive day-to-day improvements in the quality of our processes
• Work with Manufacturing, Engineering, Design, , Validation and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability
• Leverage our supplier quality and material resources to make real improvements in the quality of supplied materials
• Protect the integrity, effectiveness and timeliness of our change validation process
• Work seamlessly with the Operations / Site Leadership / Commercial / RA teams to ensure the optimal performance of the site in meeting our customer, business and regulatory commitments

Qualifications/Requirements

1. Bachelor's degree (or high school diploma/GED) plus 4 years working experience and understanding of product development, manufacturing, quality control and servicing in a pharmaceutical environment
2. Significant Multi-Modality Sites: Minimum 5 years Quality Assurance, Regulatory Assurance, or Quality Control experience in the pharmaceutical industry
3. Small and Sites: Minimum 3 years Quality Assurance, Regulatory Assurance, or Quality Control experience in the pharmaceutical industry
4. Minimum 1 year supervisory/management experience
5. In-depth knowledge in the applicable regulations (GMP, ISO etc.)
6. Prior experience using word processing, spreadsheet, and presentation software
7. Demonstrated experience with regulations in the pharmaceutical industry
8. Knowledge in qualification, validation processes
9. Strong communication skills (verbal and written), ability to communicate using English and / or local language

Desired Characteristics

1. Black Belt or Green belt certification & Lean manufacturing experience
2. Proven managerial/leadership skills such as work planning, delegating & evaluating
3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
4. Demonstrated expertise 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.
5. Demonstrated collaboration, negotiation & conflict resolution skills
6. Excellent oral communication & report, business correspondence & procedure-writing skills
7. Proven mentoring and coaching abilities, demonstrated ability to motivate & inspire others
8. Proven leadership skills (experience successfully managing people/projects/issues)
9. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
10. Change agent with energy, passion & enthusiasm to drive change
11. Demonstrated effective interpersonal, teamwork & networking skills
12. Exceptional analytical, problem solving & root-cause analysis skills
13. Ability to make decisions, even when under pressure & take ownership for assigned projects and programs
14. Demonstrated analytical, process management skills
15. Ability to multi-task & handle tasks with competing priorities effectively
16. Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
17. External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
18. Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
19. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely

GE医疗集团提供革新性的医疗技术和服务，以满足需求，使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题，以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域，助力专业医务人员为患者提供优质的医疗服务。