Jobs in All Categories (11) Engineering & Construction (2) Healthcare (2) Project Management (1) Science & Education (6)
Remain current with the global regulatory environment and communicate impact of changes on business and product development programs.
Establish team objectives based on corporate and functional area goals, drive decision making and track cross-functional progress toward objectives.
Work with cross-functional teams to align testing schedules to meet production needs. Interact with receiving and manufacturing departments to ensure inspections are completed in a timely manner.
Assist with continued company certification to the appropriate quality system standards and regulations, and assist with all related inspections as required.
Develop and manage the project plan including a budget and timeline. Lead the development and finalization of study protocols by coordinating input from various sources including literature, experts, and internal team members.
Lead EM program and system updates and implementation. Ensures all testing/assays are performed timely, compliant and validated for accuracy.
Provides direct QA oversight of the GMP deviation, investigation, product complaint, corrective and preventive action (CAPA), and change control systems.
Development and implementation of an oversight plan that contains the strategy for clinical quality support for clinical programs as appropriate.
Support external audits (regulatory bodies and client audits) on an as need basis. Responsibilities may include hosting external audit and/or coordinating the war room activities.
Lead and execute validation activities and validation assignments supporting all technical and manufacturing involving the qualification of new and existing facilities, utilities, equipment and/or computerized systems.
Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.