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Senior Business Analyst, Pharma Information Systems - GxP - Remote, US
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Job Description
- Req#: 472
Employer Industry: IT Services for Pharma and Biotech
Why consider this job opportunity:
- Salary up to $95/hr.
- Opportunity for career advancement and growth within the organization
- Work remotely 90% of the time with flexibility to accommodate various time zones
- Engage in a client-facing role with the chance to influence stakeholders across departments
- Supportive and collaborative work environment with a proven leadership team
- Opportunity to work on innovative projects within the regulated pharmaceutical and biotech industry
What to Expect (Job Responsibilities):
- Elicit, document, and manage business and system requirements, translating them into functional specifications while collaborating with stakeholders
- Lead and support GxP validation activities, including writing and executing test protocols (e.g., IQ/OQ/PQ)
- Create and maintain controlled documentation, such as Standard Operating Procedures (SOPs) and validation plans
- Analyze data to identify and implement process improvements using digital tools to support decision-making
- Participate in project teams, providing support for GxP-relevant systems and managing their lifecycle
What is Required (Qualifications):
- Minimum 6-10 years of experience in pharmaceutical manufacturing, drug safety, and clinical IT business analysis
- Proven experience in a regulated pharmaceutical, biotech, or life sciences environment with deep GMP/QA/validation knowledge
- Strong knowledge of GMP, GxP, GLP, and FDA 21 CFR Part 11 compliance
- Proficiency in data analysis tools such as SQL, PowerBI, Excel, Tableau, and Spotfire
- Bachelor’s degree in a relevant field such as Pharmacy, Life Sciences, Information Technology, or Business
How to Stand Out (Preferred Qualifications):
- Professional certifications in Business Analysis (e.g., CBAP) or project management (PMP, Scrum Master)
- Familiarity with pharmaceutical manufacturing systems like LIMS, MES, and EHR integration
- Hands-on experience in Pharmacovigilance & Adverse Event Reporting
- Experience in creating user stories in JIRA and defining functional and technical requirements
- Ability to manage multiple fast-paced projects simultaneously
#ITServices #PharmaceuticalIndustry #RemoteWork #CareerGrowth #GxPCompliance
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