Senior Manager / Associate Director, Quality Ops (Biologics)

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

TG Therapeutics is seeking a Sr. Manager/Associate Director of Quality Operations to oversee external drug product manufacturing and lifecycle activities for its biologics portfolio, including both commercial and clinical-stage products.

You will provide quality oversight of CMOs and GMP suppliers, lead batch disposition, and drive investigations, CAPAs, and technology transfer. The role requires strong leadership, cross-functional collaboration, and a track record of maintaining inspection

Qualifications

• Minimum 7 years in GMP Quality or biologics manufacturing.
• Thorough knowledge of cGMP regulations, Quality Systems, batch release, deviations, CAPAs, and validation.
• Proficiency with electronic QMS platforms (e.g., Veeva).
• Strong analytical, communication, and leadership skills.
• Ability to operate independently with minimal oversight.

Responsibilities

• Provide quality oversight of CMOs and GMP suppliers.
• Lead batch disposition.
• Evaluate complex manufacturing issues.
• Review deviations, investigations, and validation activities.
• Support technology transfer, process validation, and supplier governance.
• Ensure inspection readiness and continuous quality improvement.
• Manage Quality Agreements, audits, and regulatory interactions.
• Collaborate cross-functionally to support product supply and compliance.
• Lead quality performance metrics.

Skills

Quality oversight

CMO management

GMP compliance

Batch disposition

Deviations investigations

Technology transfer

Process validation

Supplier governance

Audit management

Regulatory interactions

Tools

Veeva

Job description

TG Therapeutics is seeking a Sr. Manager/Associate Director of Quality Operations to oversee external drug product manufacturing and lifecycle activities for its biologics portfolio, including both commercial and clinical-stage products.

You will provide quality oversight of CMOs and GMP suppliers, lead batch disposition, and drive investigations, CAPAs, and technology transfer. The role requires strong leadership, cross-functional collaboration, and a track record of maintaining inspection