Sr. QA Specialist, Raw Material Quality

Reporting to the Associate Director of Raw Material Quality, this individual will be responsible for ensuring GMP compliance of raw material management activities internally and externally for Alnylam's pipeline.

• 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%.

• 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.).

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U.S. Pay Range

$104,000.00 - $140,800.00

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.