KBI Biopharma
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."
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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."
#J-18808-Ljbffr