Senior QA & QC Leader, Biotech Manufacturing

Orca Bio; Princeton (NJ); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Equity (pre-IPO)

Annual bonus

Medical, dental & vision

PTO

401(k)

Job summary

Orca Bio seeks a Manager, Quality Assurance – East Coast to lead QA and QC at the new East Coast manufacturing site. You will ensure cGMP compliance, oversee documentation, release activities, and partner with Manufacturing, MSAT, Supply Chain and Regulatory to keep production on schedule.

The role requires a strong background in biotech manufacturing quality, regulatory inspections, and building robust quality systems.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline required; advanced degree preferred.
• 7+ years of experience in pharmaceutical or biotech manufacturing quality, with at least 5 years in a leadership role.
• Strong background in cGMP regulations and clinical manufacturing (Phase I–III); experience with biologics, cell & gene therapies, or sterile manufacturing is highly desirable.

Responsibilities

• Provide operational leadership of the site Quality function, including QA Operations, Quality Systems, QC, and Compliance.
• Ensure site Quality activities are conducted in compliance with cGMP requirements and regulatory expectations.
• Serve as the primary site Quality partner to Manufacturing and cross functional teams.
• Maintain a state of inspection readiness and promote a culture of quality and continuous improvement.
• Oversee batch record review and disposition of products and materials.
• Lead deviation investigations, change control, CAPA, and complaint management per site needs.

Skills

QA Leadership

cGMP

Cross-functional leadership

Regulatory understanding

Biologics/Cell Therapy

QA Operations

Education

Bachelor’s degree in science or engineering

MS/PhD preferred

Tools

LIMS

Regulatory documentation systems

Job description

Orca Bio seeks a Manager, Quality Assurance – East Coast to lead QA and QC at the new East Coast manufacturing site. You will ensure cGMP compliance, oversee documentation, release activities, and partner with Manufacturing, MSAT, Supply Chain and Regulatory to keep production on schedule.

The role requires a strong background in biotech manufacturing quality, regulatory inspections, and building robust quality systems.