Principal Specialist

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. 

Position Summary:

This position resides within the Computer System Quality (CSQ) department within Global Quality. The selected individual will ensure the quality of the enterprise software validation in a Contract Development and Manufacturing Organization (CDMO) setting.  Individual will be responsible for the review and approval of enterprise software validation lifecycle deliverables and the quality oversight of Change Controls, CAPAs, and Deviations associated with enterprise software. This individual provides strategic and technical expertise for global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and KBI internal requirements.

Responsibilities:

• Provide quality assurance review and approval for validation lifecycle deliverables of enterprise software projects.
• Provide quality assurance review and approval of enterprise software Change Controls, CAPAs, and Deviations.
• Provide support for Data Integrity global initiatives and remediation.
• Provide quality oversight of Global Information Technology systems.
• Provide support for developing the Global Computerized System Validation Program.
• Partner and collaborate with the IT Computer Systems Validation team to apply risk-based strategies to enterprise systems.   

Requirements: 

• BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent.
• Experienced in Computer System Validation, Data Integrity, and IT Quality in an FDA regulated manufacturing environment.  Demonstrate expert knowledge of 21CFR, Part 11, and/or EU Annex 11.
• Working knowledge of ISPE GAMP 5 Guidance 2nd edition for a risk-based approach to compliant GxP computerized systems.
• Ability to read, analyze, and interpret general business periodicals, professional journals, or governmental regulations. 
• Ability to author reports, business correspondence, templates, and procedures. 
• Ability to read and analyze validation lifecycle documentation.
• Ability to effectively communicate with staff, colleagues, managers, and clients.
• Ability to solve practical problems and deal with a shifting variables in situations where only limited standardization exists.

Salary Range: $118,000 - $162,800

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. 

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. 

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.