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Principal Specialist - IT Quality
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Job Description
- Req#: R00008055
Employer Industry: Biopharmaceutical Development and Manufacturing
Why consider this job opportunity:
- Salary range of $120,000.00 - $150,000.00 per year
- Opportunity for career advancement and growth within a global leader in biopharmaceuticals
- Engage in impactful work that supports the development of new medicines and vaccines
- Work in a collaborative and innovative environment focused on quality and compliance
- Contribute to the advancement of over 160 drug candidates from preclinical to market
What to Expect (Job Responsibilities):
- Audit and manage process improvements across the employer's IT infrastructure
- Provide program oversight and quality authority for IT Compliance related SOPs and policies
- Review and approve all Software Administrative SOPs within the global network
- Serve as the global oversight and quality approver for IT-related CAPAs, change controls, and deviations
- Ensure compliance with cGMPs, legal, and regulatory requirements related to IT infrastructure
What is Required (Qualifications):
- Bachelor’s degree with 8+ years of experience or Master’s degree with 6+ years of experience in a QA or GMP environment or equivalent
- Advanced knowledge of IT infrastructure best practices in a pharmaceutical setting
- Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment
- Demonstrated expert knowledge of 21 CFR Part 11 and EU Annex 11
- Strong analytical and problem-solving skills
How to Stand Out (Preferred Qualifications):
- Experience working in a Contract Development and Manufacturing Organization (CDMO)
- Familiarity with quality management systems and regulatory compliance in biopharmaceutical manufacturing
- Proven track record of successful process improvement initiatives in IT environments
#Biopharmaceuticals #QualityAssurance #ITCompliance #CareerGrowth #RegulatoryStandards
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