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Quality

Manager/Senior Manager, Quality Systems, Computer System Assurance (GXP)

  • Cambridge, MA
  • Added
Asset 1

Position Overview:

The Manager of Quality Systems, Computer System Assurance will act as a leader in the Quality organization and will be responsible for all aspects of computer systems validation and qualification activities as part of an overall Software/System Development Lifecycle (SDLC) approach. This role leads CS validation on various technology development and implementation projects, including documented plans, test scripts development, testing, and support. The Manager of Quality Systems, Computer System Assurance (CSA) will also support oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, CSV procedures, and Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems.


The Manager of Quality Systems, Computer System Assurance (CSA) is also responsible for supporting system related issues, employing risk-based methodology, and ensuring all GxP computerized systems are maintained in a validated state throughout their lifecycle. This position reports to the Associate Director of Quality Systems (GxP).

Primary Responsibilities:

  • Works closely with Global and NC teams to ensure alignment and good communication with key Stakeholders in IT and Business areas.
  • Liaises with the IT team to build alignment between IT roadmap, strategies, and processes.
  • Works with consultants in Demand Management for all CSV related projects and changes.
  • Leads management of risk-based strategies and system impact assessments of regulated IT systems.
  • Develops and manages GxP system lifecycle documentation, including Validation Plans, System Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's, Change Control Documentation, and reports.
  • Manages all aspects of the CSV activities as they pertain to SDLC, including project deliverables, developing validation strategies, document development/ execution, and document reviews.
  • Ensures all policies, processes and applications/ systems managed by IT are in GxP compliance through embedded compliance in phases for design, development, testing, documentation, implementation, training, and maintenance.
  • Actively collaborates with project stakeholders and the IT team to define needs and achievable solutions and/or justifications to system requirements and system improvements.
  • Ensures initiation/preparation, documentation and closeout of all CSV related deviations and change control documents.
  • Solves problems during CSV process and address/advise on issues such as deficiencies and deviations.
  • Ensures Data Integrity principles and processes are part of the Computer System Validation processes.
  • Supports any improvements and updates to the Validation Lifecycle Management System (Kneat).
  • Leads the review of the CSV procedures in IT including all forms and templates in alignment with main QS procedures.
  • Provides the necessary oversight of system related issues, employ risk-based methodology, lead teams on those assessments and ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle.
  • Supports any audits and external regulatory inspections for all processes and documentation related to the IT CSV processes and validated systems.
  • Leads and contributes documenting RACIs for the CSV and IT Change Management processes.

Qualifications:

  • Bachelors or Advanced degree in Computer Science, Pharmaceutical sciences, Biotechnology Engineering or technical field OR the equivalent combination of bachelor’s degree and CSV and GxP years of experience as required.
  • 5-8 years of experience in a Computer Systems Validation position/ role developing and implementing related processes and documentation.
  • Experience in Data Integrity, Periodic Reviews, Risk Management, Change Management, and Access Monitoring/ Management.
  • Deep understanding of System Development Life Cycle (SDLC), GAMP 5, 21 CFR Part, 210, 211, 11, and Annex 11.
  • Experience developing validation documentation and testing protocols (IQ/OQ/ UAT) within various SDLC phases, and processing documentation using Validation Lifecycle Management Systems (Kneat preferred).
  • Experience with the following systems preferred – Veeva QualityDocs, QMS, Kneat, DocuSign, PCS, BAS, EMS, SAS, SAP, IRT systems, Clinical & Regulatory SaaS systems.
  • Knowledge/experience in CSA (Computer Software Assurance) and related processes/ documentation.
  • Experience validating and qualifying applications for different business areas as HR, Supply Chain, Manufacturing, Labs, Regulatory, and Quality Systems, between others.
  • Experience with presenting and explaining CSV documentation and processes, and establishing actions plans for any possible observation or recommendation.
  • Experience using Microsoft Office software, as well as application of technical writing best practices and principles.
  • Experience writing, reviewing, and approving procedures and compliance documentation.
  • Experience interacting with regulatory health authorities at pre- and post-approval inspection.
  • Ability to analyze situations, present alternatives and lead to establish/ define solutions and related action plans.
  • Must be able to effectively work in a fast-paced environment, be flexible, and possess the ability to adapt to shifting priorities, to work independently as well as part of a team.
  • Good in hands-on and end-to-end CSV projects experience and application of project controls - including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management.
  • Ability to manage complex projects and timelines in a matrix team environment. Able to independently identify compliance risks and escalate when necessary. Able to lead meetings to evaluate CSV implications in projects and proposed changes.
  • Ability to work with multiple areas, stakeholders, team members and project managers while being able to manage priorities and solve issues.
  • Excellent written and verbal communication skills. 

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