Manager, CSV & Data Integrity

Job description

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**
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.

About Charles River's CDMO Services

With over 20 years of experience and industry-leading expertise, Charles River's cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization.

Our integrated, phase-appropriate CDMO capabilities-including plasmid DNA, viral vector, and cell therapy manufacturing-enable seamless development and faster timelines.

With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support.

Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs.

From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We're committed to providing benefits that elevate your quality of life.

Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminal penalties and civil liability.

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 crrecruitment_US@crl.com.

This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

230329

Required Skill Profession

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