BD (Becton, Dickinson and Company) Associate Director, Quality in Columbus, Nebraska
Job Description SummaryReporting to the Director of Quality Management, the Associate Director provides direct management of the Quality activities and personnel for the Columbus West manufacturing plant. The role contributes to the definition of the strategy and determines the tactics required to achieve plant/business unit/function objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations. Success is measured in terms of the frequency and scale of product quality organizational issues as well as business process effectiveness. Through stakeholder engagement; and people development; the Associate Director produces durable and industry leading results supporting key business drivers.
Appointed as the Management Representative for the Columbus West Plant. Responsibilities include: 1) ensuring processes needed for the quality management system are established, implemented and maintained; 2) reporting to top management on performance of quality management system and any need for improvement through Management Review meetings; and 3) ensuring the promotion of awareness of regulatory and customer requirements throughout the organization. Primary contact for the Columbus West site for FDA, ISO and other third-party inspections/audits of the quality system and/or the state of regulatory compliance for the Columbus West plant. Oversees the quality activities and compliance programs for the plant including CAPA, MRR, Temporary Deviations, Internal Audits, Supplier Audits, Change Control, Calibration, Complaint Investigations, etc. Oversees the product release (laboratories and product release personnel) to ensure that safe and effective product is distributed to the field. Responsible for approval or rejection of components, finished products, and documents to achieve this purpose. Assure that the manufacturing and support areas are compliant to regulations, standards, and internal procedures. Support continuous improvement activities for manufacturing and quality systems. Oversee training / development activities for quality personnel in the plant. Lead development of local quality strategy, ensuring alignment with company, Unit and functional strategies. Development, management and monitoring of tactical plans to achieve strategy Ensure the plant/functional quality organization is organized and resourced to fulfill its obligations and to comply with applicable regulations and procedures. Mentor and develop personnel, including dedicated succession planning and contingency management. Effectively navigate and lead through the challenges of change and establish key stakeholder engagement focused on win-win solutions. Continuously evaluate progress toward objectives adapting them to meet customer and business needs Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives Manage customer impacting issues; prioritizing quality and compliance minded solutions that uphold the company and its standards. Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors. Pursue and maintain functional knowledge of global regulations May have P&L accountability Often serves on Leadership Teams such as ESC (Executive Steering Committee), Plant LT (Leadership Team), Extended Quality LT Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies.
Member of the Plant Leadership Team and Plant Executive Steering Committee (ESC) to support plant initiatives and goals. Responsible for developing and maintaining the strategic quality plan and policies to define the overall quality practices, resources and activities to meet business and regulatory requirements for quality of products and services. Direct Quality Assurance projects through the Plant Quality Leadership Team and Quality Executive Steering Committee to sustain regulatory compliance and support plant goals/continuous improvement efforts. Responsible for the development of the quality function and associates. Responsible to assure that all quality department associates in the plant are trained to adequately perform their assigned quality responsibilities. Responsible for the Quality department and laboratory budget for the plant. Assist Associate Managers of Quality, Quality Engineers, Production Managers, Manufacturing Engineers and Supervisors on identification of root cause of quality problems on floor or customer complaints. Familiar with new product development through the GPDS process to support product and process development in the manufacturing site and assist with Design Transfer of products from design to manufacturing. Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous waste regulations. Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles. Other duties as assigned.
Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence. Supervision includes, Associate Managers, Quality Manufacturing Departments, Quality Engineers, Associate Manager (Lab), Associate Manager (Site Validation Lead), Associate Manager (Lead Auditor), and QC Leader (SLP).
Typically requires a minimum of a Bachelor's degree in science, engineering or other relevant discipline with a minimum of 8 years with relevant supervision.
Strong technical, problem solving, and statistics background
QSR/cGMP knowledge, auditing experience, experience with design of experiments, six-sigma certification, and knowledge of lean manufacturing techniques are desirable
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA NE - Columbus (West)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status