What are the responsibilities and job description for the Senior/Principal IT Validation and Compliance position at KBI Biopharma?
This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements.
Job Responsibilities :
- Provide oversight of enterprise software validation from a global perspective.
- Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.
- Provide oversight and management to validation managed services for associated projects
- Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.
- Provide support for data integrity global initiatives.
- Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software
This position will be based in Durham, NC and will require a regular site presence.
Minimum Requirements :
Salary Range :
118,000 - $162,800 (Senior)
133,000 - $183,700 (Principal)
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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
Salary : $118,000 - $162,800
