Entrada Therapeutics · 3 hours ago
Manager, GMP Quality Assurance (CONTRACT)
Boston, MA
Contract
Hybrid
Senior Level
5+ years expEntrada Therapeutics is a clinical-stage biopharmaceutical company focused on transforming patient lives through innovative medicines. The Manager, GMP Quality Assurance will oversee critical GMP QA activities, ensuring compliance and quality in the transition to commercial launch, while supporting various quality processes and regulatory interactions.
BiotechnologyEmergency MedicineGeneticsHealth CareMedical
Hiring Manager
Jenny Favaro
Responsibilities
Support critical manufacturing and laboratory investigations, PPQ strategy development, and regulatory interactions, ensuring a strong quality process and inspection readiness
Lead or support preparatory work for Heath Authority inspections and actively support inspection interactions
Review and approve master and executed batch records, ensuring final disposition compliance with regulatory filings and internal specifications where applicable
Review in-process, release, and stability data
Disposition lots from intermediates through finished drug product
Supports internal and external deviations, change controls, and CAPAs to closure
Monitor evolving regulatory requirements and quality trends to ensure GMP Quality readiness and proactive compliance planning
Support Vendor Management Program, including management of vendor audit activities and the Approved Supplier List
Writes and implements changes to GMP Standard Operating Procedures
Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records
Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Policies
Leads and supports understanding and adoption of risk-based approaches and decision making
Interacts with cross-functional teams across technical operations as a QA lead or resource
Supports all GxP functions as needed
Qualification
Required
Bachelors in a relevant scientific field and a minimum of 5+ years of QA experience in pharmaceutical or biotechnology companies. Experience can be considered in lieu of degree
Strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of future cGMP commercial practices
Proven experience contributing to Health Authority regulatory filings and successful inspection readiness and support for EMA or FDA
Demonstrated technical experience and success supporting clinical-to-commercial transitions in therapeutic development
Strong attention to detail and ability to communicate and collaborate with stakeholders outside of Quality
Company
Entrada Therapeutics
Entrada Therapeutics is a developer of novel therapeutics intended to treat devastating diseases.
51-200 employees
H1B Sponsorship
Entrada Therapeutics 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 (7)
2024 (14)
2023 (4)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$301.6MKey Investors
Wellington Management
2024-06-24Post Ipo Equity· $100M
2022-12-08Post Ipo Equity· $26M
2021-10-29IPO
Leadership Team
Dipal Doshi
Chief Executive Officer
Leo Qian
Co-Founder
Recent News
2025-12-17
2025-11-22
2025-11-19
Company data provided by crunchbase