Head - Supplier Quality Assurance

1 month ago

Mumbai, India Abbott Full time

The Supplier Quality Assurance Regional Manager must effectively develop, execute, and manage the Quality Assurance Department in accordance with Corporate and Divisional policies and procedures in order to assure that proper controls are instituted and maintained for all Abbott procured commodities from initial qualification through lifecycle management. The manager has overall responsibility to maintain high quality levels on all commodities while achieving high efficiency and has final authority for material related decisions including acceptance, release, and post-production assessment and events or complaints. 

Create regional strategy and manage the department responsibilities for supplier management including qualification, performance monitoring, and continuous improvement processes to achieve and maintain sustainable, quality supply. Perform/support supplier qualification assessments of new suppliers to assure the quality design of processes, facilities and systems meet AN and regulatory requirements. Work with cross functional team to develop, validate and issue qualification packages. Conduct studies at qualification to assure that testing between plant, third party lab (as applicable), and suppliers is in alignment.  Utilize monitoring policies and procedures to assure that all products generated conform to predetermined Corporate/Division standards and specifications. Anticipate issues and proactively implement preventative actions. Utilizes development programs for the continuous improvement of vendors to achieve sustainable performance which meets AN requirement. Responsible for maintaining/controlling the approved supplier status.  Maintain relevant documentation such as policies, procedures, specifications, and acceptance programs and assure these documents are current and compliant to internal policies and regulations.  Assure that proposed changes made to processes are approved and compliant to specifications, making changes when necessary. Provide support to manufacturing plants through supplier event management and identification and implementation of improvement programs as aligned with site, division, and support function leadership.  Manage recurring CAPAs on a monthly, quarterly and annual basis by evaluating exception report data and reporting information to appropriate areas of the business (i.e. Purchasing and Operations), as well as the suppliers. Support resolution and approval of exception reports within the plants. Lead investigations to resolve and troubleshoot supplier issues.  Reviews performance of the department and personnel against approved objectives, budgets and plans, and takes necessary remedial actions. Under the guidance of the Director of Quality Assurance, this position is responsible for compliance with Corporate and Divisional QA policies, procedures, standards and specifications as well as regulations in applicable countries of operation.

Bachelor’s degree

(Masters’ Degree is preferred)

Physical or life science, engineering or business A minimum of 10 years of experience in Quality, Supply Chain and Manufacturing or related experience is required. Experience working with International plants and affiliates is preferred. Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience. Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP) Expert knowledge of quality management systems and regulatory requirements.  This position requires excellent problem solving and decision making skills since the technology for many of Abbott's products are unique. This position requires a keen understanding of vendor relationship management and strategic sourcing. A thorough understanding of integrated processes and technologies involved in supply management is required.  The manager must have the ability to work and interact with many cultures in many time zones, and be capable of interpreting and analyzing technical data from different regions for decision making. The manager must have the ability to summarize and present technical recommendations and solutions to Abbott senior management 

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