The Supplier Quality Manager Single-Use CMO (Contract Manufacturing Organizations), is leading a team of Supplier Quality Engineers driving exceptional product quality, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for GEHC. This role is a key technical and leadership position, affecting product quality for both installed base and NPI and requires excellent communications and collaboration skills.
This position is responsible for the Supplier Quality oversight of CMO's producing commercial product on behalf of GEHC. The scope of this role mainly includes external Single-Use CMO's and sub-tier suppliers to these. This role is responsible for ensuring consistency of approach to management of CMO's, and for ensuring CMO's meet the quality expectations of GEHC. This role will partner closely with Sourcing, Product Management, Engineering, and QA to manage CMO's and for ensuring CMO's meet the expectations of GEHC. Strong collaboration and the ability to effectively work in a matrixed environment is critical to success for the role.
Key responsibilities include:
Lead and develop the SQE's in the team to foster high quality standards, work ethic and a positive work environment.
Oversight of the CMO program (including setting of objectives, Op Mechs, monitoring of key metrics, improvement initiatives etc.).
Monitoring and analysis of CMO program processes and continuous improvement plans of the same.
Sets goals for the function that helps drive strategy execution to enhance and maintain CMO oversight in compliance with GEHC standards.
Finding solutions to effectively navigate and correct misalignment between different stakeholders both within and outside the operating unit.
Proactive monitoring of the performance of CMOs & sub-tier suppliers to ensure that they remain in a state of control.
Leading the effort to drive improvement and for the development & assessment of quality metrics, KPIs and reports associated with CMO.
Lead team to improve supplier quality performance for assigned suppliers via Quality Plan implementation.
Lead team to approve supplier selection through robust qualification processes and part qualification.
Management of critical issues and timely resolution, developing solutions to complex problems.
Customer facing actions coordinating support for customer audits/visits, reporting out on critical & GSAM customer investigations
Supporting initiatives to reduce case management timelines.
Develop positive relationships and work closely with key stakeholders such as Sourcing, QA, GSAMs, GSAM QA Managers to manage issues drive Quality improvements that minimize the Costs of Quality, Field Failures, and Factory defects.
Lead team to ensure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process. Approval/counter approval of SCARs & other SQCS records pertaining to CMOs.
All other duties as assigned by manager.
Degree in an engineering or technical discipline or equivalent non-technical degree with experience in manufacturing, engineering or quality assurance experience.
Leadership experience in Quality Assurance, Supplier Quality, Engineering, Supplier Management.
Minimum 7 years' experience in manufacturing, design, quality assurance or regulatory assurance.
Experience in the biotechnology and/or pharmaceutical industry, preferably both
Experience in CMO operations.
Experience leading, training and/or implementing root cause analysis and effective investigation practices.
Proficiency with Microsoft Excel spreadsheet development and analysis.
Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
ASQ Certified Quality Engineer or Manager.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as Six Sigma, DFR, etc.
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
Demonstrated collaboration, negotiation & conflict resolution skills.
Excellent verbal communication & report, business correspondence & procedure writing skills.
Familiarity with various engineering areas of technology, such as, but not limited to: Single-use technology, Plastics, CMO (Process & Design capability), Chemistry.
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).