BD (Becton, Dickinson and Company) Quality Manager, AP in Tuas, Singapore

Job Description Summary

PURPOSE OF JOB

He/she is responsible for managing the Asia Pacific regional complaint center (AP RCC), customer-facing quality and ensures that the quality management system in BD Holdings are met per the relevant Standards, corporate and local Regulation requirements.

This position, in context of the strategic quality plan, will champion the enabling of continuous process improvement to support the performance and quality needs of the business and its Customers.

In general, this position is responsible for assuring that the organizational structure, responsibilities, procedures, processes, and resources for the Asia Pacific Quality System and the Quality Management organization are adequate to meet the needs of the business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies.

This position’s focus areas include but are not limited to, development of overall company and regional strategy, continuous improvement, and customer complaint/feedback management.

JOB FUNCTION

  1. Appointed by the Top Management of BD Holdings as the Management Representative.

  2. Responsible for managing and facilitating the Management Review Process such that Management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures and, that any improvements or changes in the quality system are implemented and documented.

  3. Responsible for the development and continuous improvement of the Regional Quality Management function and associates to the highest professional and performance standards.

  4. Responsible for assuring that all Quality Management function associates are trained to adequately perform their assigned quality responsibilities.

  5. Other or more specific responsibilities include:

a. Management of Customer Complaints and provide relevant customer-facing Quality support to the Business to satisfactorily address customer complaints/queries.

b. Assuring adequacy and effectiveness of investigations/testing related to product complaints or internal failures, field actions, implementation of process improvements (eg, Six Sigma, Lean), including the feedback loop to the plant.

c. Support, in collaboration with Operations, Regulatory Compliance and other responsible management and functions, of a BD Corrective/Preventive Action System and, direct responsibility for prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements.

d. Responsible for collecting, trending, analyzing and disseminating quality indicators, including but not limited to quality objectives, complaints, service levels and training.

e. Responsible for disseminating quality procedures and scheduling and tracking associated training.

f. Responsible for interpreting new and revised regulatory requirements and develop internal procedures to ensure continuous compliance.

g. Development and administration of Quality Management budget to assure adequate resourcing for Quality System and AP RCC responsibilities and quality function support of the business Quality Plan.

  1. Executes any other tasks and/or projects as assigned by the Director of Quality, Asia.

REPORTING STRUCTURE

Immediate Facilitator Director of Quality

Asia

Position Quality Manager

Direct report Senior QS Executive (Singapore),

QS Executive (Singapore)

POSITION REQUIREMENTS

Education:

BS Degree/Master’s Degree in Science/Engineering or Quality

Relevant Experience:

  1. Minimum 10 years relevant quality assurance / regulatory compliance experience in the pharmaceutical or medical device manufacturing industry.

  2. Relevant experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management.

Job Competency requirements:

  1. Leadership: Minimum of 3 years management experience; this individual must be credible as a ‘thought leader’ and able to inspire others, creating a dynamic environment that fosters innovation in thought and execution, as well as transparency; must be able to work collaboratively and lead influentially, must have exceptional judgment, integrity, and ethics.

  2. Quality Systems Track Record: Proven track record of significant accomplishments and innovation establishing progressive business practices with regard to quality.

  3. Customer focus: Is flexible and nimble in keeping up with customer needs; is on the cutting edge defining their next level of expectations, and working to exceed them.

  4. Strategic Thinker/Change Agent: High energy, accountable and forward-looking; able to see larger business picture. Persuasive individual with the ability to work at all levels to educate and gain buy-in for all regional programs and initiatives; track record of creating a positive imprint on an evolving business; able to engage in strategic business discussion and communicate the value of quality programs and initiatives and the value of change.

  5. Effective Trusted Communicator: Demonstrated ability to effectively educate and influence other stakeholders of the Quality System, encouraging ownership of quality vision and strategies; must be approachable, a good listener and trusted confidant, able to encourage confidence to receive ‘unfiltered truth’ about potential problems within the Region; and get buy in on strategies and means of implementation of such.

  6. Exceptional Problem Solver and Manager: Must be a “working manager”, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions. Must be able to roll-up his/her sleeves to get things done, non-dictatorial; he/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability. Also able to identify and alleviate any potential hurdles to achieving objectives. Must be comfortable and able to operate within a matrix organization that thrives on team work and consensus building, not on authoritative, unilateral decision making style.

Job Description

PURPOSE OF JOB

He/she is responsible for managing the Asia Pacific regional complaint center (AP RCC), customer-facing quality and ensures that the quality management system in BD Holdings are met per the relevant Standards, corporate and local Regulation requirements.

This position, in context of the strategic quality plan, will champion the enabling of continuous process improvement to support the performance and quality needs of the business and its Customers.

In general, this position is responsible for assuring that the organizational structure, responsibilities, procedures, processes, and resources for the Asia Pacific Quality System and the Quality Management organization are adequate to meet the needs of the business and conform to all applicable regulatory requirements, including all adopted industry standards and BD Corporate Quality and Regulatory Compliance Policies.

This position’s focus areas include but are not limited to, development of overall company and regional strategy, continuous improvement, and customer complaint/feedback management.

JOB FUNCTION

Appointed by the Top Management of BD Holdings as the Management Representative.

Responsible for managing and facilitating the Management Review Process such that Management with executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures and, that any improvements or changes in the quality system are implemented and documented.

Responsible for the development and continuous improvement of the Regional Quality Management function and associates to the highest professional and performance standards.

Responsible for assuring that all Quality Management function associates are trained to adequately perform their assigned quality responsibilities.

Other or more specific responsibilities include:

Management of Customer Complaints and provide relevant customer-facing Quality support to the Business to satisfactorily address customer complaints/queries. Assuring adequacy and effectiveness of investigations/testing related to product complaints or internal failures, field actions, implementation of process improvements (eg, Six Sigma, Lean), including the feedback loop to the plant.

Support, in collaboration with Operations, Regulatory Compliance and other responsible management and functions, of a BD Corrective/Preventive Action System and, direct responsibility for prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements.

Responsible for collecting, trending, analyzing and disseminating quality indicators, including but not limited to quality objectives, complaints, service levels and training.

Responsible for disseminating quality procedures and scheduling and tracking associated training.

Responsible for interpreting new and revised regulatory requirements and develop internal procedures to ensure continuous compliance.

Development and administration of Quality Management budget to assure adequate resourcing for Quality System and AP RCC responsibilities and quality function support of the business Quality Plan.

Executes any other tasks and/or projects as assigned by the Director of Quality, Asia.

REPORTING STRUCTURE

Immediate Facilitator

Director of Quality

Asia

Position

Quality Manager

Direct report

Senior QS Executive (Singapore),

QS Executive (Singapore)

POSITION REQUIREMENTS

Education:

BS Degree/Master’s Degree in Science/Engineering or Quality

Relevant Experience:

Minimum 10 years relevant quality assurance / regulatory compliance experience in the pharmaceutical or medical device manufacturing industry.

Relevant experience in quality systems for complaint management, failure investigation, corrective & preventive action, and document & quality records management.

Job Competency requirements:

Leadership: Minimum of 3 years management experience; this individual must be credible as a ‘thought leader’ and able to inspire others, creating a dynamic environment that fosters innovation in thought and execution, as well as transparency; must be able to work collaboratively and lead influentially, must have exceptional judgment, integrity, and ethics.

Quality Systems Track Record: Proven track record of significant accomplishments and innovation establishing progressive business practices with regard to quality.

Customer focus: Is flexible and nimble in keeping up with customer needs; is on the cutting edge defining their next level of expectations, and working to exceed them.

Strategic Thinker/Change Agent: High energy, accountable and forward-looking; able to see larger business picture. Persuasive individual with the ability to work at all levels to educate and gain buy-in for all regional programs and initiatives; track record of creating a positive imprint on an evolving business; able to engage in strategic business discussion and communicate the value of quality programs and initiatives and the value of change.

Effective Trusted Communicator: Demonstrated ability to effectively educate and influence other stakeholders of the Quality System, encouraging ownership of quality vision and strategies; must be approachable, a good listener and trusted confidant, able to encourage confidence to receive ‘unfiltered truth’ about potential problems within the Region; and get buy in on strategies and means of implementation of such.

Exceptional Problem Solver and Manager: Must be a “working manager”, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions. Must be able to roll-up his/her sleeves to get things done, non-dictatorial; he/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability. Also able to identify and alleviate any potential hurdles to achieving objectives. Must be comfortable and able to operate within a matrix organization that thrives on team work and consensus building, not on authoritative, unilateral decision making style.

Primary Work Location

SGP Tuas - Tuas

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.