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Position Overview:

The Manager, Digital Quality & Data Integrity will act as a leader in the Quality Systems 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, Digital Quality & Data Integrity 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 individual in this role will be integral to the Quality Assurance IT functions at our Center of Excellence (CoE) lab in Cambridge, focusing on Global computerized systems and site-based analytical instruments. This position demands a deep knowledge and awareness of validating embedded software systems within equipment. Additionally, the candidate must possess practical knowledge in applying data integrity concepts specifically tailored to analytical instruments. This position reports to the Associate Director of Quality Systems (GxP).

Primary Responsibilities:

• Collaborate effectively with Global CoE and NC teams, ensuring strong alignment and communication with critical stakeholders in IT and Business sectors.
• Work in conjunction with the IT team to align the IT roadmap, strategies, and processes cohesively.
• Engage with consultants in Demand Management for all Computer System Validation (CSV) related projects and modifications.
• Spearhead the development of risk-based strategies and conduct system impact assessments for regulated IT systems.
• Develop and oversee GxP system lifecycle documentation, including but not limited to Validation Plans, System Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ), User Acceptance Testing, Traceability Matrix, Validation Reports, Standard Operating Procedures (SOPs), Change Control Documentation, and various reports.
• Manage all facets of CSV activities for out of the box, configured (GAMP 5 Category 4) and custom software (GAMP 5 Category 5) as they relate to the Software Development Life Cycle (SDLC), encompassing project deliverables, validation strategy formulation, document creation/execution, and review processes.
• Guarantee that all policies, processes, and systems managed by IT adhere to GxP compliance, with embedded compliance in phases such as design, development, testing, documentation, implementation, training, and maintenance.
• Actively engage with project stakeholders and the IT team to identify requirements and develop viable solutions or justifications for system requirements and improvements.
• Oversee the initiation, documentation, and closure of all CSV-related deviations and change control documents.
• Address and provide guidance on issues in the CSV process, including deficiencies and deviations.
• Ensure the integration of Data Integrity principles and processes into the Computer System Validation workflow.
• Support enhancements and updates to the Validation Lifecycle Management System, particularly Kneat.
• Lead the revision of CSV procedures in IT, aligning with main Quality System (QS) procedures, including the review of all forms and templates.
• Provide oversight for system-related issues, employing risk-based methodologies, leading assessment teams, and maintaining all GxP computerized systems in a validated state throughout their lifecycle.
• Assist in audits and external regulatory inspections, focusing on processes and documentation related to IT CSV processes and validated systems.
• Lead and contribute to the documentation of Responsibility Assignment Matrix (RACI) for 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.
• 8-10 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.
• Experience validating Category 5 custom software systems in lab (e.g., Next gen sequencing Amplicon Analysis Software, etc.,)
• Experience with validating Analytical Instruments with embedded computer system software.
• 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.