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Quality Lead QA Operations (Technical)

This position is dedicated to the clinical facility
Provides quality support to Devens Site through quality review and approval of investigations and change controls. Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
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 WWQC guidelines and requirements.
Provide quality support and oversight for Manufacturing Science and Technology and validation protocols and reports.
Quality support of technical services programs.
Participates as requested in the response team for audits and inspections by world health authorities.
Major Duties
Provides quality support to Devens Site through quality review and approval of investigations and change controls.
Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems.
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 WWQC guidelines and requirements.
Provides quality support and oversight for Manufacturing Support and Validation protocols and reports.
Quality support of Technical Services programs.
Participates as requested in the response team for audits and inspections by world health authorities.
Provides Quality support for the technology transfer process for incoming molecules.
May provide guidance to less experienced staff.
Drives opportunities for continuous improvement through project leadership and group engagement.
Represents QA in cross functional meetings.
Provides training on QA owned procedures.
Knowledge and Skill
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.
Knowledge of biotech bulk and finished product manufacturing
Extensive knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, and Syncade desirable.
Past experience where one was required to work in a team based environment with a diverse group of people.
Excellent writing and oral communication skills are required.
Decision Making
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Makes sound decisions and applies appropriate notification to management as appropriate.



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