Shire Quality Lead and QMS System Administration in Lexington, Massachusetts
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.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.