Team Lead Quality Control

POSITION SUMMARY
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The Quality Manager is to conduct all departmental activities such that operations are able to supply the Global Pharmaceutical industry with a quality package delivered on time at a reasonable cost. This includes correspondence and communications internally and externally directly with customers. Reports to the VP of Quality with dotted line responsibility to the Plant Manager for reporting and resolution of quality concerns.

Is responsible for the implementation and maintaining of a system to ensure that all products manufactured by the organization meet customer specifications and achieve superior quality and reliability levels. Directly supervises Quality Specialists, Quality Engineers, and Quality Supervisor. Indirectly responsible for hourly QC and QA personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for the implementation, update and improvement to the Quality Management System to achieve transformation of the site to world class performance as measured by demanding pharmaceutical customers. Ensures that the production process and final product both meet established and anticipated customer requirements and quality standards such as ISO 9001:2015, FDA Regulations, GMP, and other relevant standards.
• Transform stated Gerresheimer Quality Strategies and Objectives into a sustainable Quality Assurance Process. Formulate and maintain Quality objectives and coordinate those objectives in cooperation with other department managers to maximize quality, reliability and to minimize costs. Integral participation in the site leadership team to achieve performance and sustainability targets as outlined in Gerresheimer’s Formula G strategy.
• Interaction with customers, understanding their quality requirements, working with Commercial Account Executives and Field Quality Engineers. High degree of customer visitation as required to engage in Quality meetings to identify opportunities to improve customer satisfaction and service as it relates to Quality
• Coordinate investigation for all customer complaints and articulate customer concerns to the internal QA, QC, and Operations Teams. Effectively and efficiently, prepare comprehensive responses to customer complaints and concerns. Work directly with Operations and SMEs to set expectations, drive accountability to the shop floor, and timely resolve complaints. Monitors / reports complaint status for Moulded Glass Americas and works to reduce, minimize and eliminate complaints.
• Coordinate with all departments to improve repeatability and consistent good quality in rapidly evolving high value product manufacturing processes. Evaluate and insist on solutions that eliminate repetitive Quality complaints and result in achieving and sustaining dimensional and cosmetic AQLs to meet customer standards.
• Responsible for the management of a team that:
  • Develops and maintains a Strategic Supplier Index and effectively manages supplier risk.
  • Coordinates and approves all sample submissions of new products and initiates change control policies.
  • Oversees lab services and compliance to requirements, both inside and outside
  • Reviews, makes recommendations and approves all credit approvals for quality complaints. Informs and notifies BU Financial Department of appropriate accrual levels
  • Oversees all activities surrounding CAPA’s and related customer interaction
  • Assists plant and company management in preparing quality related reporting and presentation materials including Operative and Strategic Plans
  • Coordinates customer specification development, related production trials and customer audits. Facilitates approval and sourcing of capacity from international Gerresheimer Moulded Glass facilities as needed.
  • Participates in plant management staff meetings and key strategic initiatives
  • Ensure plant audits are being performed to determine the effectiveness of the quality system. Ensures that all non-conforming material, either raw material or finished goods, is handled according to established policies and procedures.
  • Identifies training needs, recommends and assists in training of plant personnel in other targeted areas, as needed.
  • Consults with all segments of…