This position is responsible for management, direction and coordination of all quality activities within the plant to ensure compliance with world-wide regulations, business strategies and customer needs. This includes providing quality leadership encompassing Quality Engineering, Environmental Monitoring, and Reagent Stability Testing. The role contributes to strategy definition and determines the tactics required to achieve plant/cluster objectives.
Through outstanding communication; effective problem solving and active management of ambiguous situations; senior 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 and organizational issues as well as business process effectiveness.
Through internal and external stakeholder engagement; and people development; the Reagent Plant Quality Manager produces durable and industry leading results supporting key business drivers.
Manages and leads Quality Engineering, Stability, and Microbiology in support of Reagent manufacturing.
Accomplishes task through highly experienced professional specialists. Assess and build organization capability, mentor and develop personnel, and create succession planning and contingency management.
Provide effective leadership in teamwork development, effective communication and quick response to customers.
Drives continuous improvement in customer satisfaction.
Engage with (or lead) global quality networks as well as the business unit and associates toward the effective promotion and alignment of organizational goals to the companyâ€™s mission and vision.
Ensure the plant(s)/functional quality organization is (are) designed and resourced to fulfill its obligations and to comply with applicable regulations and procedures.
Responsible for developing, managing, maintaining, reporting and improving plant quality metrics including plant/site management review.
Evaluation of metrics to identify, escalate and drive resolution to issues. Effectively navigate and lead through change and establish global stakeholder engagement focused on win-win solutions. Ensure effective and timely CAPA implementation focused on reducing customer complaints, non-conformance's and scrap.
Support and oversee Situational Analysis completion and timeliness in support of Recall process. Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by plant/business/function objectives
Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors. May have P&L accountability Interface with
Regulatory agencies as process expert as appropriate. May act as management representative for notified body audits and liaison with regulatory authorities and customers by hosting and managing audits.
Build 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.
Bachelor's degree in science, engineering or other relevant discipline with a minimum of 6 years relevant supervision.
Knowledge and experience with IVD Reagent Manufacturing preferred.
Strong knowledge of WW Regulations, Design Controls, Risk Management and Quality Sciences.
ADDITIONAL AND PREFERRED SKILLS AND QUALIFICATIONS
Pharmaceutical knowledge is desired.
Design and Management of 21 CFR 820/210/211, ISO 14971, ISO 9001:2015, ISO 13485:2016 Quality System in compliance with unit, segment and corporate requirements
Products span IVD as well as Special Order Custom Products and Cell Therapy
The ability to prepare and understand technical documentation such as drawings, operating procedures, work instructions, validation, stability, etc.
The ability to assess and articulate risk when evaluating a situation.
The ability to communicate effectively in writing and orally, to organize work and to achieve results when working alone or in teams.
Leads cross-site business unit quality support for shared product developments and manufacturing activities
Oversees the design and management of quality related Business Systems data such as Master Data and Transactional data.
Proven track record creating an effective and highly organized quality organization.
A leader who is able to initiate change and facilitate change while encouraging participative decision making.
A leader who believes in continuous improvement at all levels, e.g., personal, interpersonal, managerial, organizational and systems.
Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence.
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