Head of Quality - Cell Therapy CDMO (Site Leader)

Cellipont Bioservices; The Woodlands (TX); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive benefits package

401K with strong employer match

Tuition reimbursement

Employee referral bonuses

Flexible work schedules

Job summary

Kincellis Advanced Therapies (formerly Cellipont Bioservices) is seeking a Site Head of Quality to define, govern, and sustain the Quality strategy for The Woodlands, TX. This senior leader will oversee Quality Control, Quality Operations, Quality Systems, Compliance, and Validation, ensuring GMP compliance, data integrity, and inspection readiness across clinical and commercial manufacturing.

The role requires robust regulatory judgment, escalation discipline, and the ability to partner with

Qualifications

• Bachelor’s degree in a scientific/technical/engineering discipline.
• Experience leading Quality units in regulated biopharma/AT/cell therapy environments.
• Strong knowledge of GMP, ICH, FDA, USP/EP/JP standards.

Responsibilities

• Provide independent Quality Unit leadership for the site with governance and resources.
• Oversee Quality Control, Quality Operations, Quality Systems, Compliance, Validation.
• Build and sustain a risk-based quality management system and CAPA effectiveness.
• Ensure inspection readiness and timely remediation of compliance gaps.
• Partner with cross-functional teams to define quality requirements and GMP readiness.
• Represent site Quality to executives, clients, regulators, and auditors.

Skills

Leadership

GMP knowledge

Regulatory engagement

Quality governance

Executive presence

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Job description

Kincellis Advanced Therapies (formerly Cellipont Bioservices) is seeking a Site Head of Quality to define, govern, and sustain the Quality strategy for The Woodlands, TX. This senior leader will oversee Quality Control, Quality Operations, Quality Systems, Compliance, and Validation, ensuring GMP compliance, data integrity, and inspection readiness across clinical and commercial manufacturing.

The role requires robust regulatory judgment, escalation discipline, and the ability to partner with