CrawlJobs Logo
Beam Therapeutics Logo Beam Therapeutics · Quality Control

Specialist, GxP Compliance & Data Integrity

United States, RTP, North Carolina 105000.00 - 145000.00 USD / Year · Job Posted January 21, 2026
Apply Position
Job Link Share

Job Description

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Quality & Data Integrity team and play a pivotal role in shaping the future of digital compliance. Unlike traditional QA roles, this position focuses on advanced computerized systems quality assurance and data integrity across local embedded computerized systems and global platforms—including SaaS, IaaS, and PaaS—critical to our digital transformation. As a trusted Subject Matter Expert, you will partner with Manufacturing, Quality Control, Validation (CQV and CSV), IT, and Automation teams to ensure seamless qualification, validation, and automation activities that meet GxP and regulatory standards. This is your opportunity to influence enterprise-wide digital strategies, drive innovation, and make a measurable impact on patient safety and product quality.

Job Responsibility

  • Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
  • Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
  • Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
  • Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
  • Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
  • Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
  • Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
  • Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
  • Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
  • Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance
  • Support periodic review activities - periodic reviews of computerized systems, user access reviews, audit trail reviews, periodic validation reviews and periodic procedure reviews and updates to maintain compliance

Requirements

  • Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
  • or Master’s degree in the same fields with 8+ years of relevant experience
  • Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
  • Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
  • Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
  • Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
  • Experience with supplier management program for computerized system suppliers
  • Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
  • Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
  • Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance
  • Excellent written and verbal communication skills
  • ability to collaborate across functions
  • Ability to work independently, manage prioritize competing priorities, and maintain compliance under tight timelines
  • Ability to lead and implement changes in QA capacity in a fast-paced and diverse environment

Nice to have

  • Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV
  • Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations
Beam Therapeutics - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Specialist, GxP Compliance & Data Integrity

8 matching positions

Senior Specialist, Quality Risk & Governance

At Amgen, we are relentless in applying the highest ethical standards to our pro...
Location
Location
United States , Thousand Oaks
Salary
Salary:
132037.30 - 178638.70 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Master's degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Bachelor's degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Associate's degree and 10 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • High school diploma / GED and 12 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Job Responsibility
Job Responsibility
  • Support implementation and continuous improvement of enterprise Quality Risk Management (QRM) frameworks aligned with global regulatory expectations
  • Facilitate risk identification, assessment, mitigation, escalation, and monitoring activities across GxP functions and sites
  • Partner with cross-functional stakeholders to identify emerging compliance and operational risks across the product lifecycle
  • Support development and monitoring of Key Risk Indicators (KRIs), quality metrics, and risk dashboards to enable proactive decision-making
  • Conduct risk trending, signal analysis, and data evaluation to identify systemic issues and opportunities for mitigation
  • Assist with governance and oversight of enterprise risk registers, risk review forums, and escalation pathways
  • Collaborate with Digital and Quality Systems teams to support risk management process integration within Veeva or other quality technology platforms
  • Support inspection readiness activities and provide SME support during internal audits and regulatory inspections related to risk management processes
  • Contribute to development of training materials and risk management capability-building initiatives across the organization
  • Monitor industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation
What we offer
What we offer
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Senior Specialist, Global IT Enterprise Core Service

The resource will be responsible for the management, evolution and security of t...
Location
Location
Italy , Pomezia; Bologna; Milano; Alanno
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong hands-on experience with Active Directory (DNS, DHCP, GPO, sites & services) and Microsoft Entra ID / Azure AD
  • Solid experience with authentication and federation technologies (SSO, MFA, Conditional Access, SAML, OAuth, OIDC, ADFS)
  • Experience with IAM / identity lifecycle and access governance
  • Experience administering Microsoft 365 collaboration services (Exchange Online, Teams, SharePoint, OneDrive)
  • Solid knowledge of server virtualization on both Microsoft Hyper-V and VMware vSphere/ESXi (vCenter, clustering, HA/DR)
  • Experience with hyperconverged infrastructure (HCI) platforms (VMware vSAN, Nutanix, Azure Stack HCI / Azure Local)
  • Working knowledge of Microsoft Azure and hybrid-cloud services (Azure Arc, hybrid identity, hybrid connectivity)
  • Ability to manage the end-to-end lifecycle of systems and infrastructure (deployment, patching, upgrades, capacity and decommissioning)
  • Knowledge of endpoint management and identity-driven security (Intune/MDM, Microsoft Defender for Endpoint) considered a plus
  • Scripting and automation skills (PowerShell, Microsoft Graph) for identity lifecycle and reporting
Job Responsibility
Job Responsibility
  • Administer and evolve identity platforms (Active Directory, Microsoft Entra ID / Azure AD), including hybrid identity and directory synchronization
  • Manage authentication services: Single Sign-On (SSO), Multi-Factor Authentication (MFA), Conditional Access and federation (SAML, OAuth, OIDC)
  • Design and operate Identity & Access Management (IAM) processes: provisioning/de-provisioning, role-based access, access reviews and privileged access management (PAM)
  • Manage and support enterprise collaboration platforms (Microsoft 365 — Exchange Online, Teams, SharePoint, OneDrive)
  • Define and enforce identity and access policies aligned with security and compliance requirements
  • Support integration of applications and services with the corporate identity platform
  • Manage endpoint identity and security integration (Intune/MDM, conditional access, device compliance) in coordination with the Workplace team
  • Manage the full lifecycle of the core-service systems (provisioning, configuration, patching, upgrades, capacity management and secure decommissioning)
  • Monitor core services health, availability and security
  • manage incidents and root-cause analysis
What we offer
What we offer
  • Competitive salary
  • comprehensive benefits
  • extensive opportunities for professional growth and development
  • Fulltime
Read More
Arrow Right

Specialist SAP Architect, ATTP

In this vital role, you will be a thought leader who helps to drive Amgen’s digi...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree OR Master’s degree in computer science or STEM majors and 4 to 6 years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM OR Bachelor’s degree in computer science or STEM majors and 6 to 8 years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM OR Diploma in computer science or STEM majors and 10 to 12 years of IT or years of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) and WM/EWM/SRM
  • Strong hands-on experience in configuring and customizing SAP ATTP with S/4HANA WM/EWM and MM. with a minimum of 1-2 end to end S/4 EWM and/or ATTP implementations
  • Hands-on SAP WM/SRM (Stock Room Management) and EWM experience, with proven expertise in solution design and configuration
  • Good understanding of SAP supply chain processes and in particular serialization, warehouse management, packaging operations with ATTP, Tracelink or SAP Information and Collaboration Hub (ICH)
  • Should have a deep knowledge of warehouse management, materials management and integration with the other modules, such as PP, QM, and SD. Knowledge of EWM is also preferred
  • Understanding of global serialization regulations and experience installing, configuring, deploying, documenting and testing systems to meet specific business requirements
  • Strong understanding of pharmaceutical serialization processes and global compliance frameworks (EU FMD, DSCSA, Russia, Brazil, etc.)
  • Experience working with SAP ICH is a plus
  • Familiarity with S/4HANA environments and upgrade/migration projects
  • Ability to test Function Module, BAPIs and knowledge on ABAP Debugging
Job Responsibility
Job Responsibility
  • Design and implementation of SAP ATTP solutions aligned with pharmaceutical serialization and regulatory compliance requirements (e.g., DSCSA, EU FMD, various country market regulations)
  • Architect, design, and optimize SAP EWM/WM solutions across Amgen’s global manufacturing, packaging, and distribution network
  • Work as part of a global SAP WM/SRM/EWM expert team, providing coverage, technical leadership, and proactive support across multiple sites and time zones
  • Define solution architecture, integration points, and data flows between SAP ATTP, SAP ECC/S4HANA (MM, PTS, PP, WM, QM), external contract packaging operations, internal manufacturing systems, external warehouse and automation systems such as ASRS, conveyor systems, MES
  • Work closely with business process owners to gather requirements, translate them into system specifications, and ensure alignment with business objectives
  • Drive solution delivery across multiple deployment phases including blueprinting, configuration, testing, and go-live support
  • Oversee system validation, serialization data management, and E2E integration testing across Logistics Service providers, contract manufacturing organizations (CMOs) and other supply chain partners
  • Provide technical leadership to internal and external implementation teams, ensuring solution scalability and performance
  • Support continuous improvement initiatives and roadmap planning for serialization and supply chain traceability systems
  • Identify and resolve data discrepancies between ERP, ATTP and EWM/WM (e.g., mismatched deliveries, open tasks, HU inconsistencies, or stock variances, serialization data) through proactive monitoring and corrective strategies
Read More
Arrow Right

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
paconsulting.com Logo
PA Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Management Consultancy experience highly desirable
  • A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
  • Typically 8+ years experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
  • Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
  • Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
  • Hands-on experience with supplier qualification, audits, CAPA and compliance management
  • Experience of RIM and PLM system implementation in regulated environments (highly desirable)
  • Knowledge of computer system validation and data integrity principles
  • Excellent problem-solving, communication and stakeholder management skills
  • QP status is highly desirable but not essential
Job Responsibility
Job Responsibility
  • QMS design and process transformation
  • Leading the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
  • Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10)
  • Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence
  • Supporting effective change management, embedding best practices through close collaboration with quality, technical and business teams
  • Computer system validation and data integrity
  • Leading and advising on computer system validation (CSV) activities within GxP environments
  • Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations
  • Supplier quality and audit support
  • Applying hands-on experience in supplier qualification, evaluation and audit activities (internal and external)
What we offer
What we offer
  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity-based initiatives
  • Annual performance-based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)
  • Fulltime
Read More
Arrow Right

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
paconsulting.com Logo
PA Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Management Consultancy experience highly desirable
  • A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
  • Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
  • Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
  • Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
  • Hands‑on experience with supplier qualification, audits, CAPA and compliance management
  • Experience of RIM and PLM system implementation in regulated environments (highly desirable)
  • Knowledge of computer system validation and data integrity principles
  • Excellent problem‑solving, communication and stakeholder management skills
Job Responsibility
Job Responsibility
  • QMS design and process transformation
  • Computer system validation and data integrity
  • Supplier quality and audit support
  • Regulatory systems implementation
  • Regulatory and Qualified Person (QP) support
  • Client and stakeholder engagement
What we offer
What we offer
  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity-based initiatives
  • Annual performance-based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)
  • Fulltime
Read More
Arrow Right

Validation Specialist

Location
Location
United States , Shawnee
Salary
Salary:
Not provided
argentaglobal.com Logo
Argenta
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a closely related field, and 2 years of experience in pharmaceutical validation, quality systems, or related GMP-regulated environments. Must have hands-on experience conducting equipment qualification (IQ/OQ/PQ) for manufacturing and laboratory equipment. Must have experience with thermal validation using Ellab or equivalent systems, including thermocouple mapping and lethality validation. Must have experience leading or supporting sterilization validation (e.g., SIP, depyrogenation, or aseptic process simulations) aligned with ISO 17665 and PDA guidelines. Must have experience with computerized system validation (CSV) in accordance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) principles. Must have experience in process validation (PV) and continued process verification (CPV), including protocol drafting, sampling plans, execution, and statistical analysis. Must have experience in cleaning validation, including MACO and PDE-based limit calculations, toxicological risk assessments, and swab sampling strategies. Must have experience with statistical tools, including JMP, for data analysis, trend monitoring, and process capability assessments. Must have experience working with cloud-based system migrations and enterprise platforms (including SAP, Empower, MODA, and Fiix). Must have experience with Quality Management Systems (QMS), including document control, audit trail review, and deviation/CAPA processes. Must have experience with FDA 21 CFR Parts 210, 211, 820, EU Annex 1, and relevant ICH and PDA regulatory standards. Must have good written and verbal communication skills in English.
Job Responsibility
Job Responsibility
  • Develop User Requirement Specifications (URS), Functional Requirements (FRS), Configuration/Design Specifications, Risk Assessments, Requirement Traceability Matrices (RTMs), Validation Plans (VMP), Test Plans, and Validation Summary Reports (VSR). Execute validation lifecycle documents including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both manufacturing and laboratory systems. Lead and support Process Validation (PV) activities: define sampling plans, verify Critical Process Parameters (CPPs), collect in-process and final product samples, and compile validation reports per ICH Q8–Q10. Support and execute Aseptic Process Simulations (Media Fills), including operator qualification, process simulation design, and result evaluation in compliance with sterility assurance standards. Perform Cleaning Validation, including swab sampling strategy, MACO/PDE-based residue limit calculations, and execution of cleaning protocols. Conduct validation of thermal processes such as Steam-in-Place (SIP) and Depyrogenation tunnels, including thermocouple mapping, endotoxin challenge studies, and F0 calculation using tools such as Ellab. Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines. Execute retrospective validation for legacy systems and close compliance gaps via change control, system remediation, and updated documentation. Support cloud-based system transitions and data migrations for systems such as SAP ByDesign, MODA, Empower, ZenQMS, and Fiix, ensuring business continuity and data integrity. Perform Continued Process Verification (CPV), using statistical tools such as JMP for trend analysis, control charting, and capability studies (Cp/Cpk). Serve as a validation representative during internal and regulatory audits
  • address audit findings through CAPAs and technical document revisions. Draft and review Standard Operating Procedures (SOPs), Risk Assessments, and final validation documentation for various qualification and compliance activities.
  • Fulltime
Read More
Arrow Right

Software Development Senior Specialist

We are currently seeking a Software Development Senior Specialist to join our te...
Location
Location
India , Noida
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred)
  • In-depth knowledge of laboratory operations (QC, stability, sample management, batch release)
  • Experience with LIMS integrations (ERP, instruments, CDS, MES)
  • Fluent or professional-level German (spoken and written) – mandatory
  • Excellent English and German communication and documentation skills
  • Strong presentation skills with the ability to confidently interact with senior client stakeholders
  • Proven experience in client-facing roles or consulting engagements
  • Ability to manage multiple stakeholders and align business and technical teams
  • Strong analytical, problem-solving, and decision-making skills
Job Responsibility
Job Responsibility
  • Act as the primary client-facing Business Analyst for LabVantage LIMS engagements
  • Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English
  • Build strong relationships with customer stakeholders across QC, QA, IT, and business teams
  • Clearly articulate solution designs, impacts, and benefits to non-technical audiences
  • Gather, analyze, and document business and functional requirements (URS, FRS, user stories)
  • Translate laboratory processes into LabVantage LIMS functional designs and workflows
  • Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities
  • Support LIMS configuration including workflows, master data, and role-based access
  • Ensure all solutions comply with GMP, GxP, and data integrity principles
  • Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices
  • Fulltime
Read More
Arrow Right

Testing & Computer System Validation (CSV) Specialist - Healthcare

We are seeking an experienced Testing & Computer System Validation (CSV) Special...
Location
Location
Canada , Ottawa
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 8+ years of hands-on experience in Testing and Computer System Validation within the Healthcare / Life Sciences domain
  • 5+ years of strong practical experience with IQ, OQ, and PQ execution
  • 5+ years of in-depth knowledge of CSV methodologies and regulatory standards (FDA, GxP, GAMP 5)
  • 5+ years of experience validating systems such as LIMS, QMS, ERP, EMR, or Clinical systems is a plus
  • Solid understanding of SDLC, STLC, and risk-based validation approaches
  • Excellent documentation, analytical, and communication skills
  • Ability to work independently and manage multiple validation activities simultaneously
Job Responsibility
Job Responsibility
  • Plan, execute, and document Computer System Validation (CSV) activities in compliance with regulatory requirements (GxP, FDA, EMA, etc.)
  • Develop and review validation deliverables including Validation Plans, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, and Validation Summary Reports
  • Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems
  • Execute manual and automated testing activities aligned with validation requirements
  • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles (ALCOA+)
  • Collaborate with cross-functional teams including Quality, IT, Business, and Vendors
  • Support audits and inspections by preparing validation evidence and responding to audit queries
  • Participate in change control, deviation management, CAPA, and periodic reviews of validated systems
  • Provide guidance and mentorship to junior validation/test team members as needed
  • Fulltime
Read More
Arrow Right