Director, GMP Quality jobs in United States
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C4 Therapeutics, Inc. · 1 day ago

Director, GMP Quality

C4 Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation to create transformative medicines. The role involves overseeing GMP Quality Assurance for clinical trial materials, ensuring compliance with GxP regulations, and supporting the quality system as the company advances its oncology programs.

Medical DeviceBiotechnologyHealthcareHealth DiagnosticsMedicalTherapeutics
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Patrick Ward
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Responsibilities

Assure quality support and oversight for the manufacture, testing, packaging, and product disposition of clinical trial materials ensuring compliance with GxP regulations and expectations
Assure quality support for analytical method development, testing, product specifications, and COA review
Assure quality support for development projects including technology transfers, qualifications, and validations
Participate in preparation of responses to regulatory agency questions
Support and oversight of stability programs including stability protocol review and approval as well as oversight of testing
Compilation and input of testing results and trend analysis
Support the development and maintenance of C4T governance documents including authoring, reviewing, and/or approving policies and standard operating procedures (SOPs)
Support the review and approval of Quality System documents including Process Change Controls, Deviations, Corrective and Preventative Actions (CAPA)
Support the Vendor Management Program including vendor assessments and oversight of audit activities
Support the Internal Audit Program including participation as an auditor and auditee

Qualification

GMP Quality AssuranceGxP regulationsQuality System ManagementAnalytical TestingVendor ManagementRegulatory ComplianceTechnical DevelopmentLeadership SkillsTeam Collaboration

Required

Bachelor's degree in a scientific field with 10+ years of experience in biotech or pharma
Full understanding of GxP regulations and regulatory compliance guidelines, including full and current knowledge of quality assurance best practices in a bio-pharmaceutical clinical environment
Demonstrated strong GMP experience with an in-depth understanding of all aspects of technical development and manufacturing from preclinical through commercialization, including validation
Proven leadership and managerial skills and demonstrated experience working across all functions and levels
Direct experience successfully working with outsourced manufacturing and testing operations

Preferred

Experience with Phase 1 Manufacturing

Company

C4 Therapeutics, Inc.

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C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives.

H1B Sponsorship

C4 Therapeutics, Inc. 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 (1)
2023 (1)
2022 (3)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$423.8M
Key Investors
RA Capital ManagementBetta PharmaceuticalsCobro Ventures,Perceptive Advisors
2025-10-16Post Ipo Equity· $125M
2023-05-30Post Ipo Equity· $25M
2022-08-15Post Ipo Equity

Leadership Team

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Kendra Adams
Chief Financial Officer
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Company data provided by crunchbase