Manager, Quality Assurance

Overview

This role is primarily responsible for day-to-day operations within the Document Control team, as well as support QMS procedural improvements and document workflow optimization.  

Summary of Key Responsibilities

Learning and Knowledge Management

• 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.

Document Lifecycle Management

• 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.

Business Process Owner IT Systems Administration & Support

• 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.

Process Improvement & Standardization

• 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.

Compliance & Inspection Support

• Participate in audits and inspections, providing document retrieval, reports and support as needed.
• Maintain global records retention compliance and coordinate archival of obsolete documentation.

Qualifications

• Bachelor’s Degree (BA/BS) and 5-7 years’ experience in an FDA regulated environment or similar experience preferred
• Prior system administration experience required, with administration of Veeva Quality Suite preferred
• Strong understanding of GxP Regulatory Requirements around Document Control and Quality Management Systems
• Experience with Clinical stakeholders and GCP regulatory requirements preferred
• 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

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U.S. Pay Range

$119,800.00 - $162,000.00

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

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel 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.