Alnylam Pharmaceuticals · 7 hours ago
Manager, Quality Assurance
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $162K/yr
5+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, committed to transforming the lives of people with rare and common diseases. The Manager, Quality Assurance will oversee day-to-day operations within the Document Control team, support QMS procedural improvements, and optimize document workflows.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Interface with Training/LMS team (set document status dates, ensure reporting)
Manage New Hire Onboarding GxP training initiatives
Facilitate GxP training needs and curricula assessments
Process and route new and revised global enterprise-controlled documents (SOPs, Work Instructions, Policies, Forms, etc.) through established workflows in electronic document management system (Veeva Quality Docs)
Responsible for day-to-day documentation operations and execution of document processing tasks, including the performance of document formatting, version control, and metadata verification to ensure accuracy and consistency
Assign and manage document effective dates, and approval routing according to global standards
Own the Periodic Review process and oversee business execution of periodic review requirements
Monitor the document records room for any new documentation requiring archival or retrieval in accordance with retention procedures
Establish and implement document retention and destruction timelines in accordance with enterprise data retention guidelines and regulatory requirements
Other document management responsibilities as determined by management
Maintain user roles, permissions, and document templates in Veeva QualityDocs
Monitor and track document workflows to ensure timely review and approval
Support system testing, change control, and updates related to document control functionality
Contribute to global alignment of document control processes and templates
Identify opportunities to streamline workflows and enhance efficiency through automation or configuration improvements
Support training and communication efforts to ensure site and global users adhere to document control procedures
Participate in audits and inspections, providing document retrieval, reports and support as needed
Maintain global records retention compliance and coordinate archival of obsolete documentation
Qualification
Required
Bachelor's Degree (BA/BS) and 5-7 years' experience in an FDA regulated environment or similar experience
Prior system administration experience required, with administration of Veeva Quality Suite
Strong understanding of GxP Regulatory Requirements around Document Control and Quality Management Systems
Self-directed and ability to independently complete projects with an eye for detail
Strong interpersonal and organization skills
Excellent computer skills including MS Word, Excel and PowerPoint
Strong technical writing skills
Project management skills
Preferred
Administration of Veeva Quality Suite
Experience with Clinical stakeholders and GCP regulatory requirements
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
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase