Genepool Networks · 7 hours ago
Director of Quality Control
Waltham, MA
Full-time
Hybrid
Director/Executive
10+ years expGenepool Networks is seeking a Director of Quality Control to lead and execute the QC strategy across their clinical-stage pipeline. This role is responsible for ensuring the quality, compliance, and readiness of drug substances and products, while managing external manufacturing and testing partners.
Staffing & Recruiting
Hiring Manager
Ariana Zanecchia Delea
Responsibilities
Develop and own the end-to-end Quality Control strategy for clinical programs, with primary execution through external manufacturing and testing partners (CDMOs, CROs, contract labs)
Ensure QC activities support clinical development milestones (IND, CTA, Phase 1–3 progression) and are inspection-ready at all times
Define phase-appropriate QC requirements, balancing regulatory expectations with the realities of a lean, clinical-stage organization
Serve as the primary QC lead for CDMO and contract laboratory oversight, including:
Review and approval of QC-related sections of quality agreements
Oversight of method qualification/validation, specifications, stability programs, and release testing
Review of deviations, OOS/OOT investigations, change controls, and CAPAs
Drive consistent quality expectations across partners and ensure timely issue resolution
Provide scientific and regulatory oversight of analytical methods, specifications, and control strategies for drug substance, drug product, and critical raw materials
Review and approve batch records, analytical data packages, and Certificates of Analysis to support clinical release
Ensure data integrity and compliance with global GMP expectations
Contribute to regulatory submissions (INDs, amendments, CTAs) by authoring and reviewing QC-related content
Act as a QC subject-matter expert during regulatory inspections and partner audits
Interface with Regulatory Affairs, CMC, and Manufacturing to align QC strategy with overall development plans
Build, mentor, and lead internal QC resources as the organization scales (initially may be an individual contributor with strategic oversight)
Partner closely with CMC, Manufacturing, Quality Assurance, and Regulatory teams to ensure an integrated control strategy
Provide clear, risk-based recommendations to senior leadership
Qualification
Required
BS in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, or related field). Advanced degree is preferred
10+ years of experience in Quality Control or Analytical Development within the biotech or pharmaceutical industry, with at least 3–5 years in a leadership role
Demonstrated experience supporting clinical-stage programs and working extensively with external manufacturing and testing partners
Strong knowledge of GMP requirements and global regulatory expectations for QC
Preferred
Experience with biologics (e.g., monoclonal antibodies, recombinant proteins, or other complex biologic modalities)
Prior experience supporting programs from early clinical development through later stages (Phase 2/3 a plus)
Background in method development, qualification, and validation for complex analytical assays
Comfort operating in a fast-paced, resource-constrained, startup or emerging biotech environment
Company
Genepool Networks
We’ve changed how biotechs engage with placement firms by offering a fixed fee model.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Rob Patten
Founder, CEO
Company data provided by crunchbase