Director Quality Control
The Position Directs the development and implementation of Quality Controls processes for environmental monitoring, incoming materials, in process controls and finished goods to meet production goals, quality and cost objectives. Prioritizes testing schedules based on production schedule, product demand, resource availability, equipment efficiency and materials supply. Manages technical resources to address non-conforming events and develops and implements long term sustainable corrective actions. Works closely with Assay Transfer group for development and implementation of appropriate test methods and product release specifications to support robust product transfer to Operations. Works cross functionally to support trouble shooting of customer complaints and product quality related issues in timely fashion. Supports VP, Manufacturing Operations to execute long-term manufacturing strategy while managing short-term objectives. Achieves results through the leadership of managerial, professional and/or support staff. Plans and administers procedures and budgets. Makes budgetary recommendation regarding hiring of direct/indirect labor, and capital expenditures. Participates in or leads Global Projects, as required. Demonstrates and advocates RMS Cultural Beliefs, Roche Values and Roche Leadership Commitments.
Essential Functions:
Directs incoming testing team, finished product testing team, technical resources for management of non-conformances, P& L achievements, budget creation and execution, and team development; provides strategic decision making, leadership, and planning including the efficient and effective use of resources Development and execution of lean initiatives to improve quality, cost reduction, operational performance and customer satisfaction. Serves as Champion of Continuous Improvement (CI) practices for the function and continue to promote and embed CI practices within organization Lead the development of production quality standards, methods, policies and procedures through managing product requirements, obtaining R&D and Manufacturing Technologies consultation, and determining equipment and departmental needs. Manage non-conforming events - LEE, OOS, NCR & CAPA - by conducting effective root cause investigations and implementing corrective actions. Continue to monitor effectiveness by data analytics and improvising procedural controls Drive the development and implementation of improved Quality Control processes through monitoring and observation of current systems and experimental review and validation of new systems. Develop and maintain internal KPI's to demonstrate performance of the function Manages instrument capacity and resources to support daily production, trouble shooting and validation needs Partners with critical suppliers to standardize specifications and material acceptance criteria which may include supplier process development/audit/value engineering, etc Coordinates with Operations and Development design transfer teams for developing robust test methods and product release specifications to support efficient product transfer Supports manufacturing and technical support team for quick issue resolution for daily production, optimize processes with process engineering team and validation of production and process control parameters Coordinates with supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution hub Implement and maintain cGMP (current Good Manufacturing Practices) standards. Audit and certification of all products to ensure they meet specifications and regulatory requirements Prepare and manage budgets and resources. Assigns projects to appropriate personnel and monitors progress and completion. Provides guidance to subordinates to achieve goals in accordance with established policies. Other duties as assigned. MINIMUM
Qualifications:
Formal Training/Education:
Bachelor's degree required Master's degree in Life Sciences/Engineering discipline preferred. Ph.D. degree preferred.
Experience:
Minimum of 10 years of progressive experience in diagnostics/medical device manufacturing environment, quality control, non-conformance management, process control, product transfers, requirements development and creating & implementing quality compliance processes. Experience in data driven decision making in a regulated environment. Knowledge, Skills, and Abilities:
Demonstrated experience developing quality compliance processes, utilizing LeanSigma tools, data analytics and process controls in a best-in-class manufacturing environment. Proven track record of driving and leading change. Strong organizational and problem-solving skills including the ability to develop and follow written procedures, document work accurately and guide others in the same. Key attributes:
Strong leadership, Technical expertise preferably in Assays, data analytics, decision making, quality mindset, team player, strategic thinker Leadership skills to manage technical personnel - technicians, scientists Knowledge of department finance and project P&L.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Essential Functions:
Directs incoming testing team, finished product testing team, technical resources for management of non-conformances, P& L achievements, budget creation and execution, and team development; provides strategic decision making, leadership, and planning including the efficient and effective use of resources Development and execution of lean initiatives to improve quality, cost reduction, operational performance and customer satisfaction. Serves as Champion of Continuous Improvement (CI) practices for the function and continue to promote and embed CI practices within organization Lead the development of production quality standards, methods, policies and procedures through managing product requirements, obtaining R&D and Manufacturing Technologies consultation, and determining equipment and departmental needs. Manage non-conforming events - LEE, OOS, NCR & CAPA - by conducting effective root cause investigations and implementing corrective actions. Continue to monitor effectiveness by data analytics and improvising procedural controls Drive the development and implementation of improved Quality Control processes through monitoring and observation of current systems and experimental review and validation of new systems. Develop and maintain internal KPI's to demonstrate performance of the function Manages instrument capacity and resources to support daily production, trouble shooting and validation needs Partners with critical suppliers to standardize specifications and material acceptance criteria which may include supplier process development/audit/value engineering, etc Coordinates with Operations and Development design transfer teams for developing robust test methods and product release specifications to support efficient product transfer Supports manufacturing and technical support team for quick issue resolution for daily production, optimize processes with process engineering team and validation of production and process control parameters Coordinates with supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution hub Implement and maintain cGMP (current Good Manufacturing Practices) standards. Audit and certification of all products to ensure they meet specifications and regulatory requirements Prepare and manage budgets and resources. Assigns projects to appropriate personnel and monitors progress and completion. Provides guidance to subordinates to achieve goals in accordance with established policies. Other duties as assigned. MINIMUM
Qualifications:
Formal Training/Education:
Bachelor's degree required Master's degree in Life Sciences/Engineering discipline preferred. Ph.D. degree preferred.
Experience:
Minimum of 10 years of progressive experience in diagnostics/medical device manufacturing environment, quality control, non-conformance management, process control, product transfers, requirements development and creating & implementing quality compliance processes. Experience in data driven decision making in a regulated environment. Knowledge, Skills, and Abilities:
Demonstrated experience developing quality compliance processes, utilizing LeanSigma tools, data analytics and process controls in a best-in-class manufacturing environment. Proven track record of driving and leading change. Strong organizational and problem-solving skills including the ability to develop and follow written procedures, document work accurately and guide others in the same. Key attributes:
Strong leadership, Technical expertise preferably in Assays, data analytics, decision making, quality mindset, team player, strategic thinker Leadership skills to manage technical personnel - technicians, scientists Knowledge of department finance and project P&L.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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