Senior External Quality Operations Specialist

Keenova Therapeutics plc; United States; Remote; USD 80,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Bonus eligibility

Job summary

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and build strong relationships with CMOs. The role includes batch review, release activities, and governance across a multinational supply chain.

You will work with cross-functional teams to ensure compliance with quality systems and regulatory expectations. The role emphasizes collaboration with CMOs, continuous improvement, and post-launch support while maintaining rigorous oversight

Qualifications

• Bachelor's Degree in scientific discipline; preferred 5–7 years' experience as a Quality Specialist.
• Direct experience with Quality Systems (deviations, change controls, training, supplier qualification and document management systems).

Responsibilities

• Batch review and approval of CMO documentation for batch production.
• Review batch records, address discrepancies and escalate as needed to management.
• Prepare disposition and release certification for reviewed batch records.
• CMO governance; oversight of third-party supplier activities for manufacture, packaging and testing.
• Regular communication with CMOs to ensure timely manufacture and resolve quality issues.
• Continuous monitoring of product and performance from CMOs; quality record management including deviations, change controls, CAPAs.
• Monitor cold-chain transportation, qualification and routine CMO maintenance.
• Input into Technical Quality Agreements; post-launch quality activities support.
• Management of delegated projects; stability program; protocol review and approval; data review and audits.
• Drive the audit readiness program to ensure constant audit compliance.
• Champion continuous improvement efforts for projects identified at CMOs or Keenova.

Skills

cGMP knowledge

GDP knowledge

ISO 13485 knowledge

Quality systems

Education

Bachelor's Degree in scientific discipline

Job description

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and build strong relationships with CMOs. The role includes batch review, release activities, and governance across a multinational supply chain.

You will work with cross-functional teams to ensure compliance with quality systems and regulatory expectations. The role emphasizes collaboration with CMOs, continuous improvement, and post-launch support while maintaining rigorous oversight