Quality Manufacturing Lead

Sofie Co.•Haverhill, MA

12d•Onsite

About The Position

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. Key responsibilities are performed in real-time on the manufacturing floor during early production hours to provide quality oversight of the operations. This includes observing operations to prevent defects and quality events. Also, the role includes promptly initiating exception reports, escalating Customer/Product Nonconformance Reports (CPNRs) to the appropriate partners, and leading investigations, as needed. The Quality Manufacturing Lead serves as a key liaison between the Operations and Quality teams. This role requires a professional with strong technical, quality, and operational knowledge, as well as an understanding of regulatory requirements and manufacturing realities. This balance enables practical, compliant recommendations and continuous improvements.

Requirements

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.

Nice To Haves

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.

Responsibilities

Ensure real-time process evaluation and confirmation of standard work by observing operations, learning processes, and preventing errors from propagating through the production flow.
Engage with operators through direct observation, encourage “first time right” execution, answer questions, participate in crisis management, and support other quality leadership initiatives.
Address process issues and inconsistencies through structured continuous improvement activities (e.g., kaizen events, root cause analysis) and update standard work instructions and SOPs accordingly.
Ensure real-time quality metrics, process performance indicators, and problem-solving boards are visible and maintained in production areas.
Ensure exception reports (Deviation, Out-of-Specification, No Yield, Atypical Production Investigations, etc.) are created promptly when events occur; initiate troubleshooting and investigations as required.
Ensure that investigations are performed and documented appropriately and that corrective and preventive actions are implemented in accordance with corporate CAPA, deviation, and OOS procedures.
Ensure team members are trained and authorized to identify, escalate, and participate in resolving quality issues; encourage operators to identify problems and stop processes when necessary to fix issues and foster a sense of ownership.
Verify that personnel are properly trained and qualified, and that all training records are accurately documented using the Absorb training platform.
Maintain oversight of all manufacturing and quality control records for GMP batches of PET drug products in accordance with 21 CFR Part 212.
Ensure components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved prior to batch release.
Ensure 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.
Notify management of issues related to personnel, equipment, or facility conditions that require corrective action.
Ensure deviations from standard procedures are documented and justified in batch records.
Ensure compliance with all applicable SOPs and regulatory requirements, including 21 CFR Part 212 (and Part 211, as applicable).
Apply QA processes and procedures to ensure consistent product quality and regulatory compliance.
Collaborate effectively with the Facility Manager and Operations team to support problem-solving and continuous improvement initiatives.
Review documents associated with the site QA program for completeness, accuracy, and compliance.
Write, review, approve, and implement procedures, specifications, processes, and methods as required.
Liaise with internal and external inspectors and representatives on QA-related topics.
Conduct ongoing review of aseptic operations to ensure compliance with internal procedures (e.g., gowning, cleaning, sanitation, sterility assurance, environmental monitoring) and USP/FDA regulations.
Ensure product complaints are managed in accordance with company SOPs and FDA requirements.
Open and manage change controls; initiate, maintain, and review SOFIE network and site-specific procedures related to assigned job functions.
Attend quality and operational meetings; interface with Corporate QA and Operations on quality-related issues and provide management with status updates as required.
Maintain extensive working knowledge of SOFIE products and quality processes.
Assist with quality review and approval of LIMS jobs prior to batch release.
Review and release product batch records as primary or secondary QA, as assigned.
Perform other duties as required.