Manager, CSV & Data Integrity

Job Summary

Manage staff specific to computerized system validation projects. Provide support for CSV staff, System Owners and System Administrators of computerized systems/laboratory instrumentation. Coordinate with operations, quality assurance, information technology, and vendor staff, to assure that vendor qualification deliverables, validation documentation, and validation activities comply with regulatory requirements for computer system validation. Support client and regulatory audits specific to computer system validation.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

•    Responsible for personnel management activities such as: scheduling, personnel actions
•    (hiring, promotions, transfers, etc.), training and development, providing regular direction and
•    feedback on performance, disciplinary actions and delivering annual performance and salary
•    reviews.
•    Schedule staff resources to align with site validation project priorities ensure deliverables
•    comply with regulatory requirements and site policies.
•    May assist in the development of short- and long-range operating objectives, organizational
•    structure, staffing requirements and succession plans.
•    Work closely with Operational, Quality Assurance and IT staff to promote the understanding of
•    computerized system validation, regulatory requirements, and corporate policies.
•    Proactively identify opportunities for process enhancements and implement innovative solutions
•    to drive efficiency, quality, and effectiveness, fostering a culture of continuous improvement.
•    Manage the full lifecycle of validation projects, ensuring timely delivery, meeting specifications,
•    and maintaining quality throughout.
•    Prepare clear and concise validation deliverables for computerized systems, including
•    Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments,
•    Test Scripts, Traceability Matrices, and Validation Summary Reports.
•    Provide ongoing support for Data Integrity projects to identify and ensure the safeguarding of
•    data in compliance with site procedures, regulatory requirements, and corporate policies.
•    Assist system SMEs in the preparation of test scripts comprising formal testing of functional,
•    system and regulatory requirements in conjunction with computerized system validation.
•    Oversee test script execution.
•    Manage multiple validation projects simultaneously, ensuring timely completion and effective
•    communication of project timelines and milestones using appropriate tools.
•    Provide guidance and support to junior staff members on Computer System Validation (CSV)
•    practices, helping develop their skills and knowledge in regulatory compliance, validation
•    processes, and industry best practices to ensure high-quality work and professional growth.
•    Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.
•    Contribute to the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts to ensure compliance with applicable regulatory requirements, guidelines, procedures, and policies.
•    Assist, as needed, during client and regulatory audits related and help resolve or mitigate audit findings related to system validation.
•    Adhere to pertinent regulatory requirements and departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols.
•    Perform all other related duties as assigned.

Job Qualifications

•    Education: Bachelor's degree (B.A./B.S.) or equivalent in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
•    Experience: 7 to 10 years of experience in computer system validation within a regulated industry (pharmaceutical, medical device, biotechnology).
•    Minimum of 5 years of experience managing personnel.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification/License: Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training desired.
•    Other: Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 11 as they pertain to computerized systems, is required.
•    Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and a professional maturity are required.
•    Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.
•    Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point, Teams, SharePoint).
•    Strong leadership ability, project management, and facilitation skills required.
•    Must have excellent leadership skills, including the ability to influence others and obtain results without direct reporting relationships.

Compensation Data

The pay range for this position is $120,000 - $140,000.  Please note that salaries vary within the range based on factors but not limited to experience, skills, education and location.