Senior Site Quality Leader – Advanced Therapy Manufacturing

Cellipont; Research Forest (TX); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

401K with strong employer match

Tuition reimbursement

Employee referral bonuses

Flexible work schedules

PTO and paid holidays

Job summary

Kincellis Advanced Therapies (formerly Cellipont Bioservices) is seeking a Site Head of Quality to oversee and lead The Woodlands, TX Quality Unit, ensuring GMP compliance, release oversight, and inspection readiness for clinical and commercial AT manufacturing.

The role reports to the Chief Quality Officer and requires strong regulatory credibility, risk management, and leadership to sustain a compliant, data-integrity-driven operation across Quality Control, Operations, Systems, and Validation.

Qualifications

• Bachelor's degree in a scientific or technical field required.
• 10+ years leadership in biopharma, biologics, AT, or cell therapy manufacturing.
• 8+ years people leadership in quality teams.
• Senior-level quality leadership in regulated biopharma environments, with cell therapy preferred.
• Deep knowledge of GMP, ICH, FDA, USP/EP/JP and global standards.

Responsibilities

• Provide independent Quality Unit leadership for the site with governance, escalation pathways, and resources.
• Oversee Quality Control, Quality Operations, Quality Systems, Compliance, Validation.
• Strengthen client relationships and serve as escalation point for client-facing quality issues.
• Advance a risk-based QMS through governance, management review, quality metrics, and CAPA discipline.
• Ensure inspection readiness with GMP systems, documentation, data integrity oversight, and remediation of gaps.
• Champion a prevention-focused quality culture aligned with regulatory expectations.

Skills

Executive leadership

Quality governance

GMP compliance

Regulatory engagement

Data integrity

Quality systems

Risk management

Education

Bachelor's degree

Advanced degree preferred

Job description

Kincellis Advanced Therapies (formerly Cellipont Bioservices) is seeking a Site Head of Quality to oversee and lead The Woodlands, TX Quality Unit, ensuring GMP compliance, release oversight, and inspection readiness for clinical and commercial AT manufacturing.

The role reports to the Chief Quality Officer and requires strong regulatory credibility, risk management, and leadership to sustain a compliant, data-integrity-driven operation across Quality Control, Operations, Systems, and Validation.