Title:  Manager, QC

Job Summary

In this role, you will lead the Quality Control team and provide end-to-end oversight of mold monitoring, incoming material control, in-process, semi-finished and finished goods inspection, and batch release activities. You will ensure QC operations are executed timely and in compliance with approved procedures, customer requirements, cGMP guidelines and applicable quality standards, while partnering closely with Production, Engineering, Supply Chain, Technology Transfer and Quality Assurance to drive investigations, technical support and continuous improvement.

Essential Duties and Responsibilities

• Manage the QC team comprising Associate Managers, Engineers, Team Leads and Technicians to ensure timely execution of mold monitoring, incoming material sampling and testing, and IPC, SFG and FG visual and dimensional inspections in compliance with approved procedures and cGMP requirements.
• Oversee incoming material and batch release activities to ensure only conforming materials and products are released based on approved specifications, inspection plans and supporting records.
• Review and approve inspection and testing results, product disposition decisions and quality records associated with raw materials, in-process products, semi-finished goods and finished goods.
• Provide technical ownership for raw material inquiries related to inspection plans and RMTS, ensuring requirements, methods and acceptance criteria are accurate, current and aligned with site and customer expectations.
• Create, review and revise product inspection plans through SAP and ensure changes are properly assessed, approved, implemented and communicated to relevant stakeholders.
• Support technology transfer activities, including risk assessment, equivalency studies, part number setup, validation support and readiness of QC inspection and release requirements for new or changed products.
• Review gamma irradiation certificates (if required) and Certificates of Analysis to confirm completeness, accuracy and compliance prior to product use or release.
• Prepare sample Certificates of Analysis in response to customer requests and coordinate required data with the relevant stakeholders in a timely manner.
• Manage low yield and rheology deviations by leading investigations, root cause analysis, product impact assessment and effective CAPA implementation.
• Manage quality issues arising from manufacturing processes, including deviations, OOS and non-conforming products, to ensure timely containment, investigation and resolution.
• Apply effective containment, segregation and bracketing decisions for rejected or suspect product to prevent unintended release of non-compliant materials or products.
• Trend rejection, yield, rheology, inspection and release data to identify recurring issues, assess performance and drive continuous improvement with Operations and cross-functional partners.
• Perform regular process audits and Gemba walks to verify compliance with GMP, approved procedures, data integrity requirements and good inspection practices.
• Maintain QC operations and associated systems in compliance with applicable corporate procedures, customer requirements, ISO 15378, ISO 9001 and other relevant regulatory standards.
• Develop, coach and qualify QC team members; ensure appropriate training, workload prioritization and succession planning to support reliable day-to-day operations and project deliverables.
• Prepare and communicate QC metrics, lead cross-functional quality improvement projects, and perform other duties as assigned by the manager.

Education

• Minimum Bachelor’s degree or equivalent in Science, Engineering, Life Sciences or a related discipline.

Work Experience

• Minimum 8 years of experience in quality control and/or quality assurance in cGMP manufacturing environment.
• Minimum 5 years of people management or supervisory experience.
• Experience in pharmaceutical or medical device manufacturing environment is preferred.

Preferred Knowledge, Skills and Abilities

• Strong knowledge of cGMP, GDP and Data Integrity (ALCOA+) requirements.
• Good working knowledge of ISO 15378, ISO 9001 and relevant customer and specification requirements.
• Knowledge of incoming material control, batch release requirements, product disposition and non-conformance management.
• Familiarity with inspection plan creation and change management and with raw material specification or test method related requirements.
• Understanding of technology transfer, validation support and risk-based quality planning.
• Ability to review gamma irradiation certificates and Certificates of Analysis with attention to completeness, traceability and compliance.
• Strong analytical, problem solving and decision-making skills with the ability to interpret data and trends.
• Deep understanding of root cause analysis, CAPA and structured problem-solving tools such as A3 or Six Sigma.
• Strong leadership qualities and ability to manage multiple priorities in a fast-paced manufacturing environment.
• Excellent communication and interpersonal skills with the ability to interact effectively with customers and stakeholders at all levels locally and globally.
• Good project management and organizational skills that enable planning, prioritization and achievement of goals.
• Proactive, self-motivated and results-oriented with sound judgment and assertiveness.
• Experience with SAP or other quality or ERP systems is advantageous.
• Able to comply with the company’s quality policy and safety policy at all times.