Job Description Summary

Job Description

The Director of Quality, CAPA will be responsible for developing, establishing and maintaining CAPA programs, policies, processes, procedures and culture.  They will ensure that CAPA performance requirements are established and maintained for all Medication Management Solutions (MMS) product platforms.

This position leads the CAPA team and is charged with defining and executing superior CAPA practices, in accordance with The BD Way and Quality Management Systems requirements.  The Director will be a key member of the Quality Systems Team and as such they and their team will represent the interests of Quality and Compliance within the Medication Management Solutions business unit.  This position reports to the Sr. Director, WW Quality Systems MMS and is on the succession path for functional leadership.

The Director of Quality, CAPA will help drive the MMS business strategy as follows:

CAPA Program Management – this position is responsible for the effectiveness of the MMS CAPA Program.  As such, defining and maintaining a comprehensive CAPA Program for all products is required and this position is responsible for understanding where and how improvements should be made to the program to ensure effective resolution of CAPAs.

CAPA Compliance – this position is responsible for ensuring the MMS Quality Management System elements affecting CAPA are effective and efficient enabling risk control and reduction.  Compliance to requirements is a must.  This leader shall be proficient in the CAPA process requirements and leading the organization through the necessary diligence and decisions related to conformance to those requirements throughout the CAPA life cycle.

CAPA Excellence – while quality principles are well-founded in our industry, the position is responsible for identifying superior CAPA processes to enable compliance and suitable product quality levels. 

CAPA Culture – this position is responsible for defining and influencing a CAPA culture that enables deliberate compliance to quality management system requirements.

Responsibilities:

This leader must develop strategic CAPA improvement programs and represent CAPA expert-level leadership and guidance for a dedicated team. 

MMS BU-wide authority and accountability for developing, deploying, and maintaining a robust and compliant quality management system for CAPA.

Actively identify improvements to the processes within the QMS to enhance both compliance and quality.

Provide excerpt-level understanding of CAPA requirements and how to deploy them in a large-scale and rapidly evolving business.

Provide CAPA leadership during FDA and Notified body site inspections.

Acquire and develop leaders and teams to support the MMS mission and actively manage bench-strength and succession planning.

Provide diligent and fact-based communication to Executive Management team, peers, and team.

Maintain effective CAPA-related Quality Metrics and define and execute activities to improve performance. Actively support and demonstrate the BD values in daily work.

Other assignments as directed by the Sr. Director, WW Quality Systems MMS.

Requirements:

Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline.  Graduate degree preferred.

At least 10 years of experience in a pharmaceutical, medical device or other regulated field (GMP mainly, GLP, GCP) with specific experience in CAPA Management

Proven ability as a change agent to drive improvements across a large organization.

Demonstrated experience establishing global Quality strategy & oversight, QMS etc., at business/manufacturing site level in a global company.

Strong technical writing experience required.

Excellent problem solving and analytical skills.

Ability to develop creative approaches and solutions necessary to resolve complex problems.

Strong communicator capable of interfacing at senior levels.

Proven ability to work globally; ability to lead a global team and lead across cultures and regions.

Understanding of the application of quality systems to the medical device industry.

Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.

Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.

Travel is required, given the global scope of the role, and would vary in intensity depending on the evolving business needs.  Anticipated travel on a global basis to be around 10%.

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