Job ID R-301990
Job Description Summary
Reporting to the Senior Director, Corporate Quality Systems, the Associate Director Quality Systems, assumes responsibility for the design, creation, effective functioning, and specific elements maintenance of a fully integrated WW Quality System.
This position is responsible to support the development of a unified BD Quality System for specific quality system (QS) elements. These specific activities include; but, are not limited to:
- Strategic Planning & Leadership: Collaborates with the Corporate Senior Director, Quality Systems, aligning with the Senior Leadership of Quality and Regulatory within the Business Units and Regions, to implement and maintain a unified, flexible, efficient and robust Quality System.
- Develops and executes streamlined and harmonized implementation of QS elements across BDX.
- Evaluates and reviews assigned QS elements progress.
- Identifies and implements opportunities for continued improvement:
- Baselines the current QS element, establishes relevant metrics with common definitions and identifies areas of improvement.
- Collaborates with all business units, manufacturing sites, distribution centers, and/or regions on any requests/ suggestions for QS element improvement opportunity.
- Works in partnership with otherNetwork Leaders / BU Quality System Leaders for the support of the global quality system.
- Organizational Consulting/Change Management: Continually assess the components of the Quality System, associated processes and electronic solutions via two way feedback from the Businesses, Plants, Regions, and networks to provide continual improvement.
- Identifies, communicates, resolves, and escalates any quality system related risk that may potentially derail/delay objectives or adversely affect the Quality System.
- Infrastructure Development: Collaborate with the Global Quality leaders and in conjunction with the Corporate Senior Director, Quality Systems, to develop and enhance process / system performance capability of the Quality / Regulatory Organization.
- Ensures effective adoption, implementation and review of quality programs, collaborates with relevant management to gain buy-in/ownership of quality initiatives.
- Analyzes, trends, and communicates all improvement opportunities to the appropriate senior management in an effort to enhance the Quality System.
- EDUCATION AND EXPERIENCE REQUIREMENTS
- Education: BS in Science/Engineering or relevant discipline required.
- Experience: Eight or more years of Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices or diagnostics. Working knowledge of 21 CFR820, ISO 13485, MDD, IVD, MDSAP and other global regulations. Experience with sterile medical devices helpful. Capable of assisting in the development of regulatory compliance strategies.
- Leadership: Minimum of 8 years management experience; 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 systems.
- Strategic Thinker/Change Agent: Perceived as thought leader possessing knowledge of larger business picture. Influential individual with the ability to work at all levels to educate and gain buy-in for all Network 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: Demonstrate ability to effectively educate and influence other stakeholders of Quality Systems, encouraging ownership of quality vision and strategies; Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors.
- Exceptional Problem Solver and Manager: a “hands-on” analytical thinker, able to identify and diagnose problems and craft realistic solutions. Must be able to roll-up his/her sleeves to get things done, successfully establish objectives, manage people and projects, both directly and through influence, and measure results to ensure accountability, and identifies and alleviates any potential hurdles to achieving objectives. Must be comfortable and able to operate within a matrix organization.
- Ability to travel up to 25%