Treeline · 3 hours ago
Manager, Quality Assurance
Watertown, Massachusetts, United States
Full-time
Onsite
Senior Level
$136K/yr - $177K/yr
7+ years expTreeline Biosciences is focused on supporting manufacturing, clinical, and preclinical operations. The Manager of Quality is responsible for conducting audits, maintaining a quality system, and collaborating with various teams throughout drug development.
BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine
Responsibilities
Plan, conduct and close out audits for third parties (e.g. CMO, CRO, and service providers) and maintain an approved vendor list
Conduct internal GxP audits
Maintain the quality management system to ensure adherence to applicable global regulatory requirements
Conduct batch record review (Executed and Master) for all phases of manufacturing (drug substance, drug product, packaging, labeling, and associated intermediates)
Provide final disposition of finished product for clinical use, including country-specific release and collaboration with Qualified Persons (QPs)
Author and review internal and third party deviations, CAPAs, and change controls
Investigation of product complaints
Review and approval of analytical and manufacturing documentation including analytical methods; analytical qualification protocol/reports; stability protocols/reports; and specifications
QC of IMPD/IND CMC sections, as well as, clinical study documents such as protocols, IBs, etc
Review of CRO preclinical and clinical study documentation
Review and approval of clinical product labels
Authoring, revising and reviewing SOPs to ensure compliance with regulatory requirements
Implementation of process improvements
Ensuring that GMP work at contract manufacturing organizations, GLP/GCP work at sites/CROs is done in compliance with applicable laws, regulations, guidelines, and SOPs
Participation in project teams and sub-teams as needed
Qualification
Required
BA/BS in science or engineering and a minimum of 7+ years of quality assurance experience in an FDA regulated Biotech or Pharmaceutical setting
Working knowledge of GxPs (cGMP's (CFR/ICH), GLPs, GCPs), and applicable international regulations/guidelines; with strong knowledge in CMC and GMPs
Experience working in a virtual environment with Contract Manufacturing Organizations and Contract Research Organizations
Experience in batch review and release for clinical phase products
Experience reviewing manufacturing and analytical documentation
Experience authoring and reviewing SOPs, Deviations, CAPAs, and Change Controls
Experience working in Veeva
Experience performing Quality audits
Ability to manage competing priorities and timelines in a fast-paced environment
Ability to problem solve
Strong communication skills, both written and oral
Company
Treeline
Treeline (or Treeline Biosciences) is a privately held, clinical-stage biopharma company that aspires to make medicines at the highest level.
51-200 employees
H1B Sponsorship
Treeline 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)
2024 (4)
2023 (3)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$1.09BKey Investors
AI Life Sciences Investments LLCKohlberg Kravis Roberts
2025-09-03Series A· $200M
2024-10-17Undisclosed· $421M
2022-10-11Series A· $261.27M
Leadership Team
Spencer Smith
Chief Financial Officer
Recent News
2025-10-04
2025-10-01
Genetic Engineering News
2025-09-30
Company data provided by crunchbase