Manager, Quality Assurance Digital Compliance

Overview

This candidate will be responsible for managing and providing quality and compliance oversight for implementing, validating and maintaining digital technologies in accordance with existing corporate policies, procedures and FDA, EMA, MHRA, PMDA, Health Canada and other health agency regulations to ensure compliance of these digital technologies. This candidate will also lead and support activities to coordinate, maintain and manage digital technology suppliers and audits.

This candidate will lead activities across digital quality to establish a risk-proportionate, quality-driven oversight to enable data integrity and regulatory compliance.

This position is hybrid working model and will be primarily located at Cambridge, MA.

• QA lead for quality and compliance oversight implementing and validating electronic systems in accordance with corporate computer system validation/computer system assurance (CSV/CSA) procedures and requirements for the assigned digital technology.
• QA lead for quality and compliance oversight during periodic reviews of the assigned digital technologies to ensure such technology remains in a validated state.
• QA lead for change management, deviation and CAPA activities for the assigned digital technology
• QA lead for quality and compliance oversight during regulatory assessments, risk assessments, 21 CFR Part 11 and Annex 11 assessments for the assigned digital technology.
• QA lead for continuous process improvement initiatives associated with CSV/CSA processes
• Collaborate with IT and other stakeholders to develop, support and implement quantitative and qualitative real-time quality metrics and analytics
• Perform data analysis and visualization using data visualization tools and applications like Power
  
  BI etc.
• Support data governance, data management and data modelling activities for ensuring quality of data used for metrics and analytics
• Provide global QA support for assigned IT infrastructure qualification at corporate & manufacturing facilities.
• Review and approve validation artifacts (for example, Validation Plans, Specifications, Installations Qualification, Operational Qualification, Performance Qualifications Protocols, Test Scripts, Discrepancies, Trace Matrices, Summary Reports etc.) associated with the assigned digital technologies.
• Provide QA support and review system administration and maintenance procedures for the assigned digital technologies
• Manage the list of digital technology suppliers and coordinate, schedule and manage audits and questionnaires for such suppliers
• Perform internal audits and external supplier audits for digital technology
• Manage, mentor and oversee QA contractors that support implementation and validation of digital technologies as appropriate
• Perform other quality and CSV/CSA related duties as necessary.

• Bachelor's with 6-8 years or a Master's with 5-6 relevant experience in digital compliance.
• Thorough understanding of global regulations (e.g., FDA 21 CFR Part 11, Eudra Lex Volume 4 Annexure 11 etc.) and guidelines (e.g., FDA, MHRA, EMA Data integrity, ICH E6(R3), GAMP5 guidelines etc.) around computerized systems, data integrity, CSV/CSA etc. in Biotech and/or pharmaceutical industry
• Prior managerial experience under digital compliance within the Biotech and Pharmaceutical industry is required.
• Experience in coordinating and managing IT Vendor Audits is required
• Experience as a lead auditor for IT Suppliers is required
• Experience in building quantitative and qualitative real-time quality metrics and analytics is required
• Understanding and experience in using data visualization tools like Power
  
  BI is preferred
• Understanding the use of AI in GxP environment is desirable
• Good organizational, communication, and interpersonal skills
• Effective oral and written communication skills.
• May require travel up to 15% domestically and 10% internationally

$ - $

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k) with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave.

Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

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