Director, CSV and Data Integrity

Job Summary

BASIC SUMMARY: 
Responsible for management of site CSV personnel and CSV projects within Biologics Operations. Manages the validation and qualification of laboratory instrument software systems and software modifications including associated hardware/infrastructure components.
Collaborates with site and department management to identify and manage the pipeline of computer validation projects for all Biologics sites, including project management teams. 
Leads development and alignment of site-specific Data Integrity Compliance Plans (DICP), ensuring identification and remediation of data integrity compliance gaps within electronic systems, in accordance with all applicable regulations.   

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

• Lead the Biologics organization to ensure an efficient, compliant, standardized, and cost-effective CSV process across all Biologics sites.
• Manages the Biologics' pipeline of validation projects, including prioritization to ensure alignment with overall business strategic goals.
• Manage multi-site projects and programs (including CSV Initiatives) as required.
• Manage project resources in collaboration with site management, as required.
• Develop validation documentation, as required.
• Serve as a change agent within the Biologics organization, build, and motivate project teams and foster positive relationships with and among team members.
• Participates and represents Biologics as a member of the Global CSV Operations team and Computer Validation Improvement Initiative Committee (CVIIC), contributing to global forums and ensuring compliance with applicable regulations.
• Network with experts at other sites around the organization to establish and share best practices.
• Oversee the Global Biologics Validation Operations Team to ensure an efficient, compliant and cost­ effective delivery of testing, computerized system administration and validation on a day-to-day­ basis.
• Drive optimization, standardization and harmonization of computerized systems validation processes and templates between Biologics sites and with other businesses.
• Evaluate computer system validation, and system development lifecycle Industry best practices and regulatory guidance/regulations, to ensure Biologics is in compliance with regulatory expectations and following industry standards and best practices.
• Provide point of contact consultation as senior subject matter expert in the field of Computer System Development Lifecycle, Software Quality, Computer System Validation, Data Integrity and Regulatory Expectations.
• Proactively resolve conflicts between compliance requirements and project/business constraint.
• 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, as applicable.
• Assist In creation of and provide recommendations on organizational structure, staffing requirements and succession plans for CSV/Automation personnel.
• Provide recommendations for site budgets, as applicable.
• Support the policy of equal employment opportunity through affirmative action in personnel actions.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices, and procedures [SOPs, safety procedures and biosafety protocols].
• Perform all other related duties as assigned.

Job Qualifications

QUALIFICATIONS:

• Education: Bachelor's degree (B.A./B.S.) or equivalent in scientific, computer science, and engineering, or related discipline.
• Experience: 7-10 years related experience in GMP management and/or CSV validation,
• Prior experience working in a GMP laboratory with instrumentation is preferred.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: Test or validation certification preferred.
• Other: Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, and OECDs as they pertain to computerized systems is preferred. In-depth knowledge of current data acquisition technologies and state-of-the-art practices particularly in CSV and data integrity. Strong interpersonal skills including influencing and aligning. Effective communication skills for large, multinational audiences and the ability to express ideas clearly and effectively in written and oral form to all levels of the organization. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment. Demonstrated ability to build consensus and affect change across departmental boundaries.

PHYSICAL DEMANDS:

• Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• Regularly provides information to and receives information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.

WORK ENVIRONMENT:

• General office working conditions.
• The noise level in the work environment is usually quiet.

COMMENTS:   

• This position may require domestic and international travel.

Compensation Data

The pay range for this position is $155,000/yr - $200,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies