KBI Biopharma
Principal Specialist - IT Quality
This job is now closed
Job Description
- Req#: R00008055
Employer Industry: Biopharmaceutical Development and Manufacturing
Why consider this job opportunity:
- Salary range up to $150,000.00 per year
- Opportunity for career advancement within a global leader in biopharmaceutical development
- Work in a dynamic environment that supports innovation and scientific breakthroughs
- Engage in quality oversight and compliance in a regulated manufacturing setting
- Be part of a diverse and inclusive workforce that values all perspectives
What to Expect (Job Responsibilities):
- Audit and manage process improvements across the employer's IT infrastructure
- Provide 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 quality approver for IT-related CAPAs, change controls, and deviations
- Ensure compliance with cGMPs and regulatory requirements for 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
- 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
How to Stand Out (Preferred Qualifications):
- Experience in a contract development and manufacturing organization (CDMO)
- Familiarity with regulatory compliance and validation processes in biopharmaceuticals
- Strong analytical and problem-solving skills in a quality assurance context
- Previous experience working with cross-functional teams in a global environment
#Biopharmaceuticals #QualityAssurance #ITCompliance #CareerOpportunity #DiversityAndInclusion
"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."About the company
KBI Biopharma Inc. is a global Contract development and manufacturing organization (CDMO / CMO) offering Cell Line Development, Process Analytical & Formulation Development, Clinical & Commercial Manufacturing, Characterization & Cell Therapy services,...
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.