Manager, QA Manufacturing Operations - Devens MA

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory audits.

• Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation.
• Leads and provides quality oversight to automation forums. Provide review and approval of automation change management.
• Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.
• Leads the cell bank disposition program and program management. Track and review deliverables for disposition and re-evaluation.
• Support and provides quality oversight to projects and incoming transfers for cell banking operations.
• Provide quality oversight, review and approve Master Data for SAP and Syncade in support of tech transfer and projects.
• Provide quality oversight, review and approve Maximo work orders, OOTs, extensions for PMs and Cals.
• May support projects interfacing with Site Engineering.
• Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports and periodic assessments.
• Provides quality support to Devens Site through quality review and approval of deviations or change controls.
• Participates as requested in the response team for audits and inspections by world health authorities.
• Receives little supervision and identifies and reports and discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Drives opportunities for continuous improvement through project leadership, Quality systems program ownership, and group engagement.
• Represents QA in cross‑functional meetings.
• Provides training on QA‑owned procedures.
• May provide guidance to less experienced staff.
• May have direct supervision of non‑exempt and/or exempt staff.

Knowledge and Skill

• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance.
• Knowledge of Quality Risk Management principles preferred.
• Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable.
• Experience working in a team‑based environment with a diverse group of people.

• Excellent writing and oral communication skills are required.
• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.

Quality Operations – Site Support personnel may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Site Engineering, Operational…