Senior Quality Operations Manager

Scorpion Therapeutics; Newark (CA); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Scorpion Therapeutics is seeking a Senior Quality Operations Manager to oversee external manufacturing and supply chain partners in a biopharma setting. This role ensures cGMP compliance, leads QA for CMOs, and supports tech transfers and analytical activities.

You will manage deviations, investigations, CAPAs, change controls, audits, and quality reviews while driving continuous improvement and regulatory readiness. Hybrid work in Newark, CA or Waltham, MA with 2-3 onsite days.

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, or related field with 8+ years QA experience in pharma/biotech.
• Experience with CMOs, regulatory compliance, and quality systems.
• Strong knowledge of cGMP, deviations, investigations, and analytical QC.
• Excellent project management, communication, and stakeholder management skills.
• Ability to travel up to 25%.

Responsibilities

• provide daily QA oversight of CMOs, suppliers, and labs
• manage quality agreements, deviations, investigations, CAPAs, and change controls
• oversee analytical method transfers, validations, and stability programs
• support audits, inspections, and quality reviews
• monitor quality metrics and drive continuous improvement

Skills

CMO experience

Regulatory compliance

Quality systems knowledge

cGMP expertise

Deviations, investigations, CAPAs

Project management

Stakeholder management

Analytical QC knowledge

Travel readiness

Education

Bachelor’s degree in life sciences, chemistry, engineering, or related field

Job description

Role:

Senior Quality Operations Manager overseeing external manufacturing and supply chain partners in a biopharma setting.

Objectives:

ensure compliance with cGMP standards, manage quality issues, and support technology transfers and analytical activities.

Responsibilities:

• provide daily QA oversight of CMOs, suppliers, and labs
• manage quality agreements, deviations, investigations, CAPAs, and change controls
• oversee analytical method transfers, validations, and stability programs
• support audits, inspections, and quality reviews
• monitor quality metrics and drive continuous improvement

Qualifications:

• bachelor’s degree in life sciences, chemistry, engineering, or related, with 8+ years of QA experience in pharma/biotech
• experience with CMOs, regulatory compliance, and quality systems
• strong knowledge of cGMP, deviations, investigations, and analytical QC
• excellent project management, communication, and stakeholder management skills
• ability to travel up to 25%

HighValue:

• biopharma manufacturing
• external supply oversight
• cGMP compliance
• analytical validation
• regulatory readiness

WorkSetup:

hybrid in Waltham, MA or Newark, CA with 2-3 onsite days per week.