GxP Quality Director — Remote (Phase 2 Focus)

Character Bio; Brisbane, Jersey City (CA, NJ); Hybrid; USD 200,000 - 270,000; Full time

Job summary

Character Bio is a clinical-stage biotechnology company advancing two homegrown programs as it scales into Phase 2. We seek a hands-on Director/Senior Director, Quality to own the GxP quality system end-to-end, including clinical (GCP) and CMC (GMP) quality, vendor qualification, and training.

You will partner with CSO and cross-functional teams in a hybrid/remote setting from Jersey City, Brisbane, or remote.

Qualifications

• Bachelor’s degree in life science or related field required.
• 10+ years in GxP quality assurance in biotechnology or biopharmaceuticals; Sr. Director ≥3 years at Director level or equivalent accountability.
• Hands-on clinical quality for interventional trials; vendor qualification, deviation and CAPA management; inspection.
• Experience administering electronic QMS (Qualio) and training curricula.
• ICH E6(R3), ICH Q9/Q10, 21 CFR Parts 11/210/211/312 familiarity.
• Quality lead at a small company (≈100 people) with no prior quality dept.
• Willingness to be the accountable quality signature with executives, vendors, and investigators.
• Sponsor-side trial experience and ability to host sponsor inspections.

Responsibilities

• Own the clinical quality management system end-to-end (document control, training, deviations, CAPA, quality reviews).
• Maintain size/shape of procedures; author/revise/consolidate/retire SOPs with rationale and approvals.
• Serve as Qualio administrator; manage configuration, workflows, training and periodic reviews.
• Establish vendor qualification/oversight framework with defined criteria and escalation.
• Apply risk-based quality management and document risk assessments.
• Own GCP and role-based training across the company.
• Manage sponsor audits/regulatory inspections and CAPA responses.
• Oversee vendor quality events reporting and global metrics.
• Run risk-scoped audit program for vendors, sites, and processes.
• Interact with Clinical Operations, Regulatory, CMC/Biometric, etc. as quality SME.

Skills

Hands-on clinical quality

Hands-on GMP quality

Electronic QMS ownership

Quality agreement oversight

ICH E6(R3), Q9, Q10, 21 CFR Parts 11/?

Vendor qualification & oversight

CAPA & deviation management

Regulatory inspections readiness

GxP risk management

Quality leadership in small teams

Sponsor-side trial experience

Qualio administration

Procedures retirement/consolidation

Decision-making under regulatory

Education

Bachelor’s degree in life science or related field

Tools

Qualio

MasterControl

Veeva

ZenQMS

Job description

Character Bio is a clinical-stage biotechnology company advancing two homegrown programs as it scales into Phase 2. We seek a hands-on Director/Senior Director, Quality to own the GxP quality system end-to-end, including clinical (GCP) and CMC (GMP) quality, vendor qualification, and training.

You will partner with CSO and cross-functional teams in a hybrid/remote setting from Jersey City, Brisbane, or remote.