Manager, Quality Assurance

Alnylam Pharmaceuticals

2h

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• Experience with Clinical stakeholders and GCP regulatory requirements preferred

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1,001-5,000 employees