Senior Manager Computer System Validation

Planet Pharma; Redwood City (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Planet Pharma seeks a Senior Manager Computer System Validation to lead GxP validation programs for pharmaceutical and biotech systems. You will partner with IS Quality and QA to plan, execute, and document risk‑based validation for new implementations and changes.

Responsibilities include defining scope, authoring validation documents, coordinating testing, and ensuring cloud/SaaS system compliance with 21 CFR Part 11 and EU Annex 11. A minimum of 10 years in CSV is expected.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.
• 10+ years of GxP CSV experience with hands‑on validation project delivery.
• Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity.
• Ability to apply risk‑based CSV methods across the system lifecycle.
• Experience authoring and reviewing validation documents, testing, and remediation.
• Experience validating cloud/SaaS systems and evaluating vendor documentation.
• Familiarity with EDC/IRT and pharmacovigilance databases.
• Proven ability to lead multiple complex projects with minimal supervision.

Responsibilities

• Define and execute risk‑based validation approaches with stakeholders.
• Assess GxP impact, classify risk, and evaluate ERES requirements.
• Author and review validation deliverables including IQ/OQ/PM and TRMs.
• Execute testing, document evidence, and resolve discrepancies with traceability.
• Validate cloud‑based and SaaS systems and manage vendor qualification.
• Assess AI validation needs and ensure data integrity and oversight.
• Develop data migration validation and remediation activities when needed.
• Prepare change controls and ensure regulatory readiness for closures.
• Support audits, CAPAs, and periodic validation reviews.

Skills

GxP validation

21 CFR Part 11

EU Annex 11

Risk-based methods

Vendor qualification

Cloud/SaaS validation

EDC/IRT/PV experience

Audits & inspections

Documentation & testing

Education

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field

Tools

Veeva QualityDocs

Egnyte GxP

DocuSign (regulated use)

TraceLink

Job description

Senior Manager Computer System Validation

The Opportunity:

We are seeking an experienced Senior Manager Computer System Validation (CSV) to deliver validation projects for GxP computerized systems supporting pharmaceutical and biotechnology operations. Working with the Sr. Director of IS Quality, the consultant will partner with Information Sciences (IS), Quality Assurance (QA), business owners, and vendors to plan and execute validation activities for new system implementations and changes to existing systems. This role requires hands‑on development and execution of risk‑based validation deliverables, sound technical judgment, and the ability to manage multiple projects with minimal supervision. The consultant will help project teams deliver systems that meet their intended use, maintain data integrity, and be inspection ready.

Key Responsibilities:

• Define and execute risk‑based validation approaches for assigned projects, establishing scope, deliverables, responsibilities, and timelines in collaboration with IS Quality and project stakeholders.

• Assess GxP impact, classify system risk, and evaluate electronic records and electronic signatures (ERES) requirements. Translate assessment findings into appropriate validation activities and controls.

• Author, review, and assess validation deliverables for alignment with applicable requirements, including 21 CFR Part 11 and EU Annex 11. Deliverables include validation plans, user requirements, functional and configuration specifications, risk assessments, test protocols, requirements traceability matrices, and validation summary reports, as appropriate to each project.

• Execute or coordinate validation testing, document objective evidence, investigate test discrepancies, and track issues through resolution. Maintain traceability among requirements, risks, test results, and conclusions.

• Validate cloud‑based and SaaS systems, assess vendor qualification and documentation, identify gaps, and define additional testing based on system risk and intended use.

• Assess the GxP impact and risks of AI capabilities and systems and define and execute validation activities appropriate to their intended use. Partner with IS, QA, and business owners to establish acceptance criteria, data integrity controls, human oversight, and ongoing monitoring and change control.

• Develop and execute data migration validation activities when required, including migration plans, verification of data accuracy and completeness, and documentation of results.

• Prepare system change requests and assess the validation impact of upgrades, configuration changes, and other modifications. Complete required testing and documentation before project closure.

• Assess data integrity controls, including access management, audit trails, and electronic signatures. Perform or support audit trail reviews and partner with IS, system owners, and QA to resolve gaps.

• Support CSV‑related deviations, corrective and preventive actions (CAPAs), and remediation activities. Document investigations and complete assigned actions in coordination with QA.

• Communicate project progress, risks, dependencies, and decisions to stakeholders. Coordinate document reviews and approvals with designated system owners and Quality approvers.

• Support periodic reviews, system inventory updates, vendor assessments, audits, and regulatory inspections as they relate to assigned systems. Organize validation records for efficient retrieval and review.

• Author and revise CSV procedures, forms, and templates to improve the program. Guide project teams on validation expectations, regulatory requirements, and documentation quality.

Required Skills, Experience and Education:

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field.

• 10 or more years of GxP computer system validation experience in pharmaceutical or biotechnology environments, with substantial hands‑on responsibility for validation project delivery.

• Strong knowledge of GxP requirements, 21 CFR Part 11, EU Annex 11, GAMP 5, and computerized system data integrity principles and controls.

• Demonstrated ability to apply risk‑based CSV methods and computer software assurance (CSA) principles, where appropriate, across the system lifecycle; knowledge of software development and lifecycle methodologies.

• Experience authoring and reviewing validation documentation, executing testing, managing discrepancies, and supporting system implementations, change control, and remediation.

• Experience validating cloud‑based SaaS systems and evaluating vendor documentation within a risk‑based validation strategy.

• Experience working with study‑level electronic systems, including electronic data capture (EDC), interactive response technology (IRT), and pharmacovigilance (PV) databases.

• Ability to lead multiple complex validation projects with minimal supervision, meet agreed timelines, and collaborate with technical teams, QA, business stakeholders, vendors, and all levels of management.

• Experience supporting audits or regulatory inspections, with strong written and verbal communication skills, the ability to influence stakeholders, and attention to detail and quality.

Preferred Skills:

• Experience in a biopharmaceutical sponsor organization and with quality, regulatory, clinical, or safety platforms such as Veeva, Oracle Argus, TraceLink, Trial Interactive, or Medidata.

• Experience with electronic document management and electronic signature systems, such as Veeva QualityDocs, Egnyte GxP, or DocuSign configured for regulated use.

• Experience validating custom‑developed GxP applications, including defining requirements, assessing risks, developing and executing tests, and maintaining validation through software changes.

• Familiarity with IT security frameworks such as NIST, ISO/IEC 27001, and SOC 2, and privacy requirements such as GDPR, CCPA, and HIPAA.