QMS Procedural Documentation and Development
- Critical thinking to lead and support procedural document lifecycle management activities including setting timelines, document development, revision, deviations and retirement.
- Forward thinking to ensure proper utilization of Shire’s electronic management systems for document review/approval tasks, tracking and reporting.
- Lead and consult with functional area staff in identifying Quality System requirements and appropriate assignment of training to end users.
20% Process Improvement
- Apply critical thinking skills in developing innovative solutions that optimally align Quality Systems applications, associated workflows and processes to meet evolving needs of organization.
15% System Administration
- Lead technical support activities for software issues that may arise, generates and issues standard and ad hoc reports to support the business needs
- Innovative approach to user support pertaining to system access, copies of documents, trouble-shooting, problem-solving, and system enhancements.
15% Documentation & Training Material
- Develops and manages system related training material for the various users. Delivers training to new users during new hire orientation or if employee changes roles.
10% Management of ServiceNow® Inbox
- Monitor inbox to respond tickets and close out tickets upon completion.
- Create new tickets for requests received by other methods (e.g., email, telephone).
10% Inspection Readiness/PSMF Support
- Contributes to inspection readiness by participating in inspections, inspection readiness activities and regulatory agency support activities as assigned.
- Maintains the Core Quality Operations Components of the Pharmacovigilance System Master File (PSMF) to ensure Quality Operations inputs to the PSMF Annexes meet requirements.
Education & Experience Requirements
- Bachelor’s degree in a science, business or technical related field is required.
- Previous experience with Quality Management System technologies is required.
- Minimum 8 years of Pharmaceutical experience supporting GxP systems is required.
- Knowledge of US, EU, ICH regulations, guidance’s and requirements.
- Inspection support experience is desirable.
Other Job Requirements
- Responsibilities sometimes require working evenings, early mornings and weekends to cover multiple time zones sometimes with little advanced notice. Domestic and or international travel may be required.
Location/Region: Lexington, MA