Associate Director, Clinical Quality Assurance

Scorpion Therapeutics; Cambridge (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Clinical QA to provide hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. This role leads audits of CROs, laboratories, and investigator sites domestically and internationally, manages quality events, deviations, and CAPAs, and reviews key study documentation.

The incumbent will support vendor qualification, oversight, and inspection readiness, develop and maintain

Qualifications

• Bachelor's in Life Sciences or related field.
• 10+ years in biopharma/clinical research, with at least 7 years in GCP/QA roles.
• Proven experience leading vendor and site audits, including GLP nonclinical facilities.
• Working knowledge of ICH E6 (including E6 R3), 21 CFR Parts 11, 50, 54, 56, 58, 312, and EU Clinical Trials Regulation.
• Ability to travel up to 20%.

Responsibilities

• Lead audits of CROs, laboratories, and investigator sites domestically and internationally.
• Manage clinical quality events, deviations, and CAPAs.
• Review key study documentation.
• Support vendor qualification, oversight, and inspection readiness.
• Develop and maintain quality systems and SOPs.
• Track audit findings and quality metrics.
• Assist in regulatory submissions and agency inspections.

Skills

GCP knowledge

QA auditing

Vendor oversight

Regulatory readiness

Education

Bachelor's in Life Sciences

Job description

Role:

Associate Director, Clinical QA, providing hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards.

Responsibilities:

• lead audits of CROs, laboratories, and investigator sites domestically and internationally
• manage clinical quality events, deviations, and CAPAs
• review key study documentation
• support vendor qualification, oversight, and inspection readiness
• develop and maintain quality systems and SOPs
• track audit findings and quality metrics
• assist in regulatory submissions and agency inspections

Requirements:

• bachelor's in Life Sciences or related field
• 10+ years in biopharma/clinical research, with at least 7 years in GCP/QA roles
• proven experience leading vendor and site audits, including GLP nonclinical facilities
• working knowledge of ICH E6 (including E6 R3), 21 CFR Parts 11, 50, 54, 56, 58, 312, and EU Clinical Trials Regulation
• ability to travel up to 20%

High Value:

• clinical and nonclinical audits
• GCP/GLP/GCLP compliance
• vendor oversight
• inspection readiness
• regulatory support

Work Setup:

primarily on-site with domestic and international travel.