Director, CSV and Data Integrity

Req ID #:  219088

Wayne, PA, US, 19087 Malvern, PA, US, 19355

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job 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.   


  • 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


  • 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.


  • 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.


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


  • 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.


Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.


About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.


With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 


At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.


Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.


If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.


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