Role Overview for Validation Manager (CSV) – Cambridge, MA
JRG Partners, a premier HR recruiting firm specializing in connecting top talent with industry-leading organizations, is actively seeking a highly skilled and experienced Validation Manager (CSV) for one of our esteemed clients. Our client is a pioneering biotechnology company based in the vibrant scientific hub of Cambridge, Massachusetts, renowned for its innovative research and development in groundbreaking therapeutic areas. This is an exceptional opportunity for a seasoned professional to lead critical Computer System Validation (CSV) initiatives, ensuring the integrity, reliability, and compliance of vital GxP-regulated systems across the organization.
As a Validation Manager specializing in CSV, you will play a pivotal role in safeguarding data integrity and regulatory adherence. You will be responsible for the full lifecycle management of computer system validation projects, from planning and risk assessment to execution, documentation, and maintenance. This position demands a meticulous approach, strong leadership capabilities, and deep expertise in GxP regulations, including 21 CFR Part 11, Annex 11, and data integrity principles. You will be instrumental in developing and implementing robust validation strategies that align with both regulatory requirements and business objectives, contributing directly to the quality and safety of our client’s innovative products.
The successful candidate will thrive in a fast-paced, dynamic environment, collaborating closely with cross-functional teams including IT, Quality Assurance, Regulatory Affairs, and various business units. You will act as a subject matter expert, providing guidance and mentorship, and fostering a culture of quality and compliance within the organization. This role offers significant impact and visibility, allowing you to shape validation processes and drive continuous improvement within a cutting-edge scientific enterprise. If you are passionate about ensuring regulatory compliance and data excellence within the life sciences sector, and possess a proven track record in CSV leadership, we encourage you to explore this exciting opportunity in Cambridge, MA.
Our client is committed to pushing the boundaries of science and medicine, and they seek individuals who share that commitment to excellence and innovation. The Validation Manager (CSV) will be a key contributor to this mission, ensuring that the technological backbone supporting their research and manufacturing operations is robust, compliant, and trustworthy. This role is more than just managing validation; it’s about being a guardian of quality and a facilitator of scientific progress.
Key Responsibilities of Validation Manager (CSV) – Cambridge, MA
The Validation Manager (CSV) will oversee and execute a wide range of critical activities, ensuring the highest standards of computer system validation and regulatory compliance. Your responsibilities will include, but are not limited to:
Strategic Planning & Leadership
Develop, implement, and maintain comprehensive CSV strategies, policies, and procedures in alignment with GxP regulations (GLP, GCP, GMP), 21 CFR Part 11, Annex 11, and corporate quality standards. Lead and manage multiple complex CSV projects simultaneously, ensuring timely delivery and adherence to budget.
Validation Execution
Oversee and/or perform all phases of the computer system validation lifecycle, including user requirements specification (URS), functional specification (FS), design specification (DS), risk assessment, validation plan (VP) development, IQ/OQ/PQ protocol generation and execution, traceability matrix creation, and final validation report (VR) approval.
Documentation Management
Ensure all validation documentation is accurate, complete, compliant with regulatory requirements, and maintained in an organized and accessible manner. This includes managing change controls, deviation reports, and CAPAs related to validated systems.
Risk Management
Implement and manage risk-based validation approaches, identifying potential risks to data integrity and system functionality, and developing mitigation strategies to ensure compliance and operational continuity.
Data Integrity Assurance
Drive initiatives to enhance data integrity across all GxP-regulated computer systems, ensuring ALCOA++ principles are embedded in system design, use, and maintenance.
Team Collaboration & Mentorship
Collaborate effectively with IT, Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and other business stakeholders to define validation requirements and ensure successful project execution. Provide guidance, training, and mentorship to junior validation specialists and project teams.
Audit & Inspection Support
Serve as a subject matter expert during internal audits and external regulatory inspections (e.g., FDA, EMA), providing expert testimony and documentation to demonstrate compliance. Address audit findings and implement corrective actions.
Vendor Management
Work with external vendors to ensure their systems and services meet internal validation standards and regulatory requirements, including vendor qualification and audit support.
Lifecycle Maintenance
Establish and manage periodic review processes for validated systems to ensure their continued validated state throughout their operational lifecycle. Manage system decommissioning processes as required.
Process Improvement
Continuously identify opportunities for improving validation processes, tools, and methodologies to enhance efficiency, effectiveness, and compliance. Stay abreast of industry best practices and evolving regulatory landscapes, particularly concerning FDA 21 CFR Part 11 and GxP guidelines.
Requirements for the Validation Manager (CSV) – Cambridge, MA
To be successful in this critical role, candidates should possess a robust combination of educational background, professional experience, and key competencies:
Education
Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related technical field. A Master’s degree is a plus.
Experience
Minimum of 8-10 years of progressive experience in Computer System Validation (CSV) within the pharmaceutical, biotechnology, or medical device industries. At least 3-5 years of experience in a leadership or managerial capacity, overseeing CSV projects and/or teams.
Regulatory Expertise
In-depth knowledge and practical application experience of GxP regulations (GLP, GCP, GMP), particularly 21 CFR Part 11 (Electronic Records; Electronic Signatures), EudraLex Annex 11, and other relevant international guidelines for computerized systems.
Technical Acumen
Proven experience validating a wide range of GxP-regulated systems, including but not limited to: Laboratory Information Management Systems (LIMS), Electronic Document Management Systems (EDMS), Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems (e.g., SAP), Quality Management Systems (QMS), Clinical Trial Management Systems (CTMS), and various lab instruments/software.
Methodology
Strong understanding of and experience with risk-based validation methodologies and software development lifecycle (SDLC) processes.
Project Management
Excellent project management skills, with the ability to manage multiple complex projects concurrently, prioritize tasks, and meet deadlines. PMP certification or similar is a plus.
Communication Skills
Exceptional written and verbal communication skills, with the ability to present complex technical and regulatory information clearly and concisely to diverse audiences, including senior management, technical teams, and regulatory auditors.
Analytical & Problem-Solving
Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to identifying and resolving issues.
Leadership & Interpersonal Skills
Demonstrated leadership capabilities, with the ability to inspire, mentor, and motivate teams. Excellent interpersonal skills for effective cross-functional collaboration.
Quality Focus
A strong commitment to quality, compliance, and continuous improvement.
Location
Ability to work onsite in Cambridge, MA.
Benefits & Perks Offered
Our client values its employees and offers a comprehensive benefits package designed to support your health, financial well-being, and professional growth. When you join their team through JRG Partners, you can expect:
Competitive Compensation
A highly attractive salary commensurate with experience and a performance-based bonus structure.
Comprehensive Health Coverage
Robust medical, dental, and vision insurance plans for you and your family, with options for PPO and HMO plans.
Financial Security
401(k) retirement plan with generous company match, life insurance, and disability coverage.
Work-Life Balance
Generous paid time off (PTO), including vacation, sick leave, and company holidays.
Professional Development
Opportunities for continuous learning, training, certifications, and career advancement within a rapidly growing organization. Access to industry conferences and workshops.
Innovative Environment
Work in a state-of-the-art facility with access to cutting-edge technology and collaborate with some of the brightest minds in the biotech industry.
Wellness Programs
Employee assistance programs, wellness initiatives, and resources to support your overall well-being.
Company Culture
A collaborative, inclusive, and dynamic work environment that fosters innovation, respect, and teamwork. Regular company events and social gatherings.
Impactful Work
The chance to contribute to life-changing therapies and make a tangible difference in patient lives.
How to Apply
If you are a highly motivated and experienced Validation Manager (CSV) looking for a challenging and rewarding opportunity to advance your career with a leading biotechnology company in Cambridge, MA, JRG Partners invites you to apply. We are dedicated to finding the perfect match between exceptional talent and outstanding organizations.
To express your interest and submit your application, please visit our JRG Partners Life Sciences Staffing practice area page or apply directly through this platform. Please include a detailed resume highlighting your relevant experience and accomplishments in computer system validation within GxP-regulated environments.
Our team will review your application promptly and confidentially. We look forward to connecting with you and exploring how your expertise can contribute to our client’s success.
JRG Partners is an equal opportunity employer and values diversity at our client’s company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
