Senior Quality Specialist – Manufacturing

The Senior Quality Specialist – Contract Manufacturing is responsible for providing quality oversight, project coordination, and regulatory compliance support for contract manufacturing organization (CMO) activities. This position serves as a primary liaison between internal departments, external customers, and contract manufacturing partners to ensure products and processes meet established quality standards, customer expectations, and applicable regulatory requirements.

The Senior Quality Specialist coordinates cross-functional activities related to new product introductions, product changes, manufacturing campaigns, quality investigations, customer complaints, change controls, and product lot releases. This role collaborates with Product Development, Production, Quality Assurance, Quality Control, Microbiology, Chemistry, and other relevant departments to ensure projects are completed accurately, efficiently, and within established timelines.

The position also supports customer audits, regulatory inspections, continuous improvement initiatives, and the effective execution of quality system processes related to contract manufacturing.

• Ensure contract manufacturing products, processes, and activities comply with company quality standards, applicable cGMP requirements, regulatory expectations, and customer quality agreements.
• Provide quality oversight and coordination for contract manufacturing initiatives, manufacturing campaigns, new product introductions, and special projects.
• Serve as a liaison between internal departments, external customers, contract manufacturing partners, and other stakeholders to support quality and operational objectives.
• Establish and maintain positive customer relationships by communicating quality performance, addressing concerns, coordinating resolutions, and providing timely updates.
• Communicate quality-related observations, discrepancies, risks, and potential violations of company policies or procedures to Executive Quality Management, as appropriate.
• Support the resolution of product, equipment, process, and manufacturing-related quality issues in collaboration with subject matter experts (SMEs).
• Develop, execute, and monitor project work plans in accordance with contract manufacturing requirements, quality system procedures, and business objectives.
• Establish project objectives, define deliverables, identify required resources, assign responsibilities, and develop realistic timelines and completion dates.
• Coordinate cross-functional activities to ensure project milestones, manufacturing requirements, and customer commitments are achieved.
• Provide project status updates, identify potential risks and delays, and communicate progress to the relevant stakeholders.
• Drive and coordinate CMO-related quality system activities, including change controls, deviations, investigations, corrective and preventive actions (CAPA), and material-related quality events, as applicable.
• Drive and coordinate CMO-related quality system activities, including change controls, deviations, investigations, corrective and preventive actions (CAPA), and material-related quality events, as applicable.
• Collaborate with the Quality Investigations team and other departments to support timely investigations, root cause assessments, and implementation of appropriate corrective actions.
• Coordinate troubleshooting activities involving equipment, manufacturing processes, laboratory testing, and product quality concerns.
• Initiate, coordinate, and monitor projects managed through the company's Quality Management System (QMS), including change controls, quality investigations, and material management activities related to contract manufacturing.
• Receive,…