Advantage Technical · 6 hours ago
Quality Assurance Manager
Cambridge, MA
Full-time
Onsite
Senior Level
5+ years expAdvantage Technical is seeking a highly skilled Quality Assurance Manager to support commercial finished goods operations and external manufacturing partners. This role plays a critical part in ensuring product quality, regulatory compliance, and operational excellence across global commercial supply activities.
Staffing & Recruiting
Hiring Manager
Bill Sunderland
Responsibilities
Serve as the primary QA representative for commercial finished goods and external manufacturing partners
Represent Finished Goods Quality Operations in routine internal meetings and during interactions with contract manufacturers
Oversee quality aspects of commercial finished goods, including:
Specifications
Qualification and validation
Drawings and artwork
Labeling and serialization
Packaging operations at CMOs
Ensure all activities comply with internal standards and regulatory requirements for U.S. commercial production
Review and approve manufacturing partner and internal Label & Pack documentation, including:
BOMs
MPRs
Product Specifications
Variable Data
Ensure proper archival of manufacturing partner documentation in Alnylam’s document management system
Manage Quality Records related to finished goods assembly, labeling, and packaging, including:
Deviations
CAPAs
Change controls
Serialization excursions
Issue escalations
Identify and recommend ongoing process improvements to mitigate risks and support efficient, compliant operations
Qualification
Required
Bachelor's degree in life sciences, engineering, or a related field
Minimum 5 years of experience in a pharmaceutical or biopharmaceutical environment
Experience with finished goods assembly, labeling, and packaging operations at external manufacturers
Strong understanding of quality systems, documentation, and regulatory expectations
Excellent organizational, written, and verbal communication skills
Strong interpersonal skills with the ability to collaborate across teams
Experience leading or training teams in root cause analysis and effective investigation practices
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical 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
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase