Quality Assurance Specialist

This candidate will be responsible for assisting quality and compliance efforts 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 support activities to coordinate, maintain and manage digital technology suppliers and audits.

This candidate will support activities across Quality Technology & Analytics 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.

Key Responsibilities

• Provide quality support and compliance to implement and validate electronic systems in accordance with corporate computer system validation/computer system assurance (CSV/CSA) procedures and requirements.
• Provide QA support for IT infrastructure qualification at corporate & manufacturing facilities.
• Develop/Review validation artifacts (for example; IT system regulatory and risk assessments, 21 CFR Part 11 and Annex 11 assessments, Validation Plans, Specifications, test scripts, Installations Qualification, Operational Qualification, Performance Qualifications Protocols, Trace Matrices and Summary Reports etc.) associated with digital technologies.
• Execute/review validation protocols and associated discrepancies pertaining to digital technologies.
• Provide QA support and review system administration and maintenance procedures
• Provide QA support and review periodic review of digital technologies to ensure such technology remains in a validated state.
• Provide QA support to digital technologies changes, deviations and CAPA
• Provide QA support for continuous process improvement initiatives for CSV/CSA processes by performing/reviewing applicable gaps and remediating such identified gaps.
• Maintain the list of digital technology suppliers and coordinate, schedule and manage audits and questionnaires for such suppliers
• Perform/support internal audits for internal IT processes and external audits for digital technology suppliers
• Performs other quality and CSV/CSA related duties as necessary.

Qualifications

• Bachelor's with 3-5 years or a Master's with 2-3 relevant experience.
• Basic understanding of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g., FDA, MHRA and EMA Data integrity guidelines etc.) around quality systems, data integrity and CSV in Biotech and/or pharmaceutical industry (GAMP5)
• Experience as a QA or Validation professional in CSV/CSA within the Biotech and Pharmaceutical industry is required.
• Experience in coordinating and managing IT Vendor Audits is required.
• Experience as a lead auditor or a co-auditor for IT Suppliers 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

U.S. Pay Range

$86,200.00 - $116,600.00

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.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.