PURPOSE AND SCOPE
Acts as a subject matter expert to ensure that FMCNA regulated computer systems are developed, validated, and maintained in compliance with corporate software validation lifecycle policies and procedures.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- A seasoned, experienced professional with a full understanding of software quality engineering, resolves a wide range of issues in creative ways.
- Represents the Quality Systems Department on software development teams as the software validation subject matter expert.
- Partners with and/or leads business teams and IT to ensure that computerized quality systems are compliant with FMCNA procedures, FDA Quality System Regulations, 21 CFR Part 11, and GAMP5.
- Leads and coordinates multiple software validation projects across FMCNA.
- Creates and/or oversees the creation of validation deliverables including but not limited to validation assessments, validation plans, test plans, test protocols, test reports, validation summary reports, and trace matrices, as needed to support local and enterprise system implementation in a regulated (FDA) environment. Leads the review and approval of validation deliverables.
- Develops and creates test protocols as necessary. Conducts independent reviews of test executions.
- Leads business owners/teams and IT in the definition and creation of business requirements, functional specifications, and system specifications, as necessary.
- Compiles, maintains, and evolves approved project deliverables.
- Communicates project and compliance issues to Quality Systems management and provide solutions to potential risks.
- Develops and project manages internal and external regulatory audits/inspections by presenting and defending system validation projects and documentation during audits and FDA inspections as the Subject Matter Expert.
- Provides guidance/direction to external contractors working on system validation projects.
- Ensures that all pertinent validation deliverables are of high product quality and are compliant with FMCNA policies/procedures.
- Works with little to no supervision to fulfill duties in accordance with requirements of the QSR regulations, GAMP5, Corporate policies and procedures.
- Follows all policies, guidelines, and SOPs as required.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Networks with senior internal and external personnel in own area of expertise.
- May provide assistance to lower level staff with more complex tasks that require a higher level of understanding of functions. Mentors other staff as applicable.
- May escalate issues to supervisor/manager for resolution, as deemed necessary.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various duties and projects as assigned by a direct supervisor.
- Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Extended computer-based work in an office environment.
- Bachelor’s Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS
- Minimum 5 to 8 years of experience in software engineering, information technology, or software quality assurance in a regulated environment; with advanced degree 3 years of experience may be acceptable.
- Thorough understanding of FDA Quality System regulations in relation to computer system validation
- ASQ CSQE Certification or equivalent preferred.
- Extensive experience with one or more of the following highly desirable: SAP, PTC, WindChill, Pilgrim.
- Excellent verbal and written communication skills.
- Excellent team work and interpersonal skills.
- Experience with spreadsheet validation.
- Very strong analytical and problem solving skills.
- Excellent attention to detail, resourceful, self-reliant, self-motivated and confident.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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