Alnylam Pharmaceuticals · 5 hours ago
Sr. QA Specialist, Raw Material Quality
Cambridge, MA
Full-time
Hybrid
Mid, Senior Level
$104K/yr - $141K/yr
5+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, and they are seeking a Senior QA Specialist to ensure GMP compliance of raw material management activities. This role involves overseeing quality systems, leading supplier investigations, and supporting audits and regulatory inspections.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Provide QA life cycle oversight over the Alnylam raw material management and related quality systems from drug discovery through to clinical and commercial operations
Own and lead Supplier Investigation Requests and Supplier Change Notifications
Provide support with vendor and material qualification activities for domestic and international suppliers of raw materials
Serve as QA contact for key raw material suppliers to support event documents (deviation, change control, etc.) and technical reports review
Provide technical expertise around raw material management and warehousing including quality and compliance standards, testing, qualification, and release
Support internal/external audits and regulatory inspections, as well as supplier audits as needed
Assist in maintenance and evolution of Alnylam’s raw material management quality systems and processes
Contribute to regulatory submissions, as appropriate
Maintain quality metrics and present the metrics data to different audience
Travel possible, up to 15%
Qualification
Required
B.S. in applicable science or engineering field
5+ years of experience in Quality Control and/or Quality Assurance is required
Established background in raw materials management
Hands-on experience processing quality records (deviation, change control, CAPA, etc.)
Experience with overseeing and coordinating work with external suppliers/vendors
Working knowledge with CFR, ICH, Eudralex and USP/EP/JP
Excellent team skills, organization, and strong interpersonal communication skills (written and verbal)
Ability to adapt to a rapidly changing environment
Proficient knowledge of common software (e.g., EXCEL, PowerPoint, Word, etc.)
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
Company data provided by crunchbase