Quality Manufacturing Lead

Quality Manufacturing Lead

Overview

The Quality Manufacturing Lead supports the Quality Management System (QMS) at the SOFIE facility during daily manufacturing operations. The role reviews and releases product batch records as a qualified Quality Assurance (QA) representative, including primary and secondary reviews, as needed, and completes other QA activities to ensure product quality and regulatory compliance.

• Reviews and releases product batch records as a qualified Quality Assurance (QA) representative, including primary and secondary reviews, as needed, and completes other QA activities to ensure product quality and regulatory compliance.
• Supports the Quality Management System (QMS) at the SOFIE facility during daily manufacturing operations.
• Ensures real-time process evaluation and confirmation of standard work by observing operations, learning processes, and preventing errors from propagating through the production flow.
• Engages with operators through direct observation, encourages “first time right” execution, answers questions, participates in crisis management, and supports other quality leadership initiatives.
• Addresses process issues and inconsistencies through structured continuous improvement activities (e.g., kaizen events, root cause analysis) and updates standard work instructions and SOPs accordingly.
• Ensures real-time quality metrics, process performance indicators, and problem-solving boards are visible and maintained in production areas.
• Ensures exception reports (Deviation, Out-of-Specification, No Yield, Atypical Production Investigations, etc.) are created promptly when events occur; initiates troubleshooting and investigations as required.
• Ensures that investigations are performed and documented appropriately and that corrective and preventive actions are implemented in accordance with corporate CAPA, deviation, and OOS procedures.
• Ensures team members are trained and authorized to identify, escalate, and participate in resolving quality issues; encourages operators to identify problems and stop processes when necessary to fix issues and foster a sense of ownership.
• Maintains oversight of all manufacturing and quality control records for GMP batches of PET drug products in accordance with 21 CFR Part 212.
• Ensures components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved prior to batch release.
• Ensures manufacturing and analytical equipment are properly maintained and calibrated, and that applicable maintenance and system suitability activities are performed within intervals specified in equipment SOPs.
• Notifies management of issues related to personnel, equipment, or facility conditions that require corrective action.
• Ensures deviations from standard procedures are documented and justified in batch records.
• Ensures compliance with all applicable SOPs and regulatory requirements, including 21 CFR Part 212 (and Part 211, as applicable).
• Applies QA processes and procedures to ensure consistent product quality and regulatory compliance.
• Collaborates effectively with the Facility Manager and Operations team to support problem-solving and continuous improvement initiatives.
• Reviews documents associated with the site QA program for completeness, accuracy, and compliance.
• Writes, reviews, approves, and implements procedures, specifications, processes, and methods as required.
• Liaises with internal and external inspectors and representatives on QA-related topics.
• Conducts ongoing review of aseptic operations to ensure compliance with internal procedures (e.g., gowning, cleaning, sanitation, sterility assurance, environmental monitoring) and USP/FDA regulations.
• Ensures product complaints are managed in accordance with company SOPs and FDA requirements.
• Opens and manages change controls; initiates, maintains, and reviews SOFIE network and site-specific procedures related to assigned job functions.
• Attends quality and operational meetings; interfaces with Corporate QA and Operations on quality-related issues and provides management with status updates as required.
• Maintains extensive working knowledge of SOFIE products and quality processes.
• Aids in quality review and approval of LIMS jobs prior to batch release.
• Reviews and releases product batch records as primary or secondary QA, as assigned.

Qualifications

• Bachelor’s degree in a scientific, medical, or quality-related field preferred, or relevant experience.
• Experience and/or comprehensive knowledge of manufacturing operations, sterile injectables preparation, aseptic processing, and aseptic product distribution preferred.
• Previous experience in Quality, Pharmacy, or CGMP manufacturing environments preferred.
• Working knowledge of USP, FDA, and cGMP regulations preferred.
• Demonstrated ability to write, review, and revise SOPs.
• Ability to read, analyze, and interpret governmental regulations, professional journals, and technical procedures.
• Ability to interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write reports, business correspondence, and procedural documentation.
• Ability to effectively present information, deliver training, and respond to questions from managers, operators, inspectors, customers, and stakeholders.
• Strong analytical and problem-solving skills, including the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Proficiency in Microsoft Office applications.
• Strong interpersonal and communication skills for interaction with site personnel, inspectors, and internal and external vendors.

Travel Requirement

• Up to 10% domestically.