Senior Quality Systems Software Architect at KBI Biopharma | chakrie

Requirements

Additional Requirements

Bachelor’s degree in Computer Science, Software Engineering, Information Systems, or related field (Master’s degree preferred).
8–12+ years of professional software engineering or application support experience.
5+ years supporting GxP-regulated systems within the pharmaceutical, biotech, or medical device industry.
Proven experience with Quality applications (commercial or custom-built eQMS platforms).
Demonstrated experience executing complex technical initiatives without direct people management responsibility.
Experience with enterprise application development and/or configuration (e.g., python, APIs, SQL, databases).
Strong understanding of Software Development Lifecycle (SDLC), Agile/DevOps practices in a regulated environment.
Experience in Computer System Validation (CSV) methodologies, data integrity principles, and audit readiness.
Experience with Computer Software Assurance (CSA)
Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations.
AA employer and actively seeks to diversify its work force. Therefore
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.

Responsibilities

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Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

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Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Everything else on this page, kept up to date and available to every member of Chakrie at no cost at all.

Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Senior Quality Systems Software Architect

Summary

Requirements

Additional Requirements

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Summary

Requirements

Additional Requirements

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