Drug Safety Manager
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location: Cambridge, Massachusetts
job type: Contract
salary: $60.00 - 70.20 per hour
work hours: 9 to 5
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
This role is in the Global Safety Regulatory Sciences (GSRS) Quality organization. The role will work with functional area experts within the GSRS organization and quality to assist with the transition of affiliates into the R&D QMS, process improvement opportunities, periodic review of documents, CAPA management, and other quality related tasks. Additionally, the role will support audits and inspections including creating story boards, document collection, and manning the audit room.
- Provide guidance and work with SMEs to evaluate processes for compliance to regulations and process improvements as needed.
- Work with areas to monitor key process metrics such as Key Performance Indicators (KPIs) or Key Quality Indicators (KQIs).
- Review and approve controlled documents, process deviations and procedural edits, and manage on-time periodic review of documents
- Manage the GSRS global audits from preparation through completion of CAPAs for designated process areas, including preparing SMEs to present their functions during audits/inspections, aid in creating storyboards, and performing duties as the Audit coordinator.
- Monitor commitments from internal audit and regulatory inspection findings and ensure accurate and timely completion of commitment
- Bachelor's Degree; science preferred.
- 5-7 years' experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences and experience working in a quality or quality systems department
- Direct experience in GCP and/or GVP regulations
skills: CAPA, GCP (Good Clinical Practice), Regulatory Affairs Operations
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.