Position Summary:
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.
Key Responsibilities
- Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation
- Maintains operating procedures for the site Quality Assurance programs to ensure consistent, high-quality materials are produced.
- Provides floor support to the manufacturing process as needed in a person-in-plant function.
- Performs review and approval of Quality, Manufacturing, and Material Specifications SOPs, documents, and batch records.
- Provides oversight to Quality walkthroughs for shutdown and inspections readiness activities and ensures program management is in compliance with site and corporate procedures.
- Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
- Establish and communicates performance objectives for Quality Assurance staff that are consistent with the business' unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
- Provide Quality review and approval of investigation records, CAPA records, change management, automation changes, and applicable document updates/creations.
- Provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
Qualifications & Experience
- 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 5 years of relevant experience in a regulated environment with at least 3 years focused on product quality.
- Knowledge of biotech bulk and finished product manufacturing 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 multi-talented, team-based environment.
