Manager, QA Engineering

Scorpion Therapeutics; Summit (NJ); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health coverage

Wellbeing support

401(k) and insurance/disability

Job summary

Scorpion Therapeutics is seeking a Manager of QA Engineering to provide quality oversight for site technology transfer activities in a clinical and commercial cell therapy CAR T manufacturing environment. You will ensure timely review of validation/qualification documents and investigations, and support change controls in alignment with company policies.

The role requires coordinating with Engineering, Facilities, ECQ, and QA teams to maintain data integrity, manage CAPA, and coach a team of

Qualifications

• BS degree required; 5+ years pharma/related industry experience.
• GMP/Quality and risk management knowledge.
• Experience creating/using user requirement specs; IQ/OQ/PQ; UAT; qualification.
• Proficient with MS Office; CMMS Maximo and EDMS/quality systems (BMSDocs, Infinity/Valgenesis).
• Strong scientific/technical judgment; CAPA/RCA; cross-functional communication; problem solving.

Responsibilities

• Support QA Engineering group activities as assigned.
• Support Qualification/Validation for QC and manufacturing equipment, utilities, and facilities.
• Review GMP system documents (procedures, forms, etc.).
• Assure calibration/maintenance programs, validation plans, qualification protocols, reports, and procedures are appropriate.
• Support investigations with impact assessment, RCA, and CAPA documentation/implementation.
• Ensure compliance with site validation master plan; support facility start-up operations/product transfers.
• Ensure data governance/data integrity compliance.
• Work with Engineering/Facilities/ECQ to meet global regulatory requirements.
• Coach and develop direct reports; lead cross-functional alignment.

Skills

GMP/Quality

Risk management

User requirement specs

IQ/OQ/PQ protocols

UAT

CAPA/RCA

Data integrity

Cross-functional communication

Problem-solving

Trend recognition

Education

Bachelor's degree

Tools

Maximo

BMSDocs

Infinity

Valgenesis

Job description

Position Summary:

Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities) provides quality oversight for Site Technology Transfer activities in a clinical and commercial cell therapy CAR T manufacturing environment. Ensures timely review of validation/qualification documents, technology transfer documents, investigations, and evaluation of change controls (aligned to BMS policies/Global cGMP).

Duties/Responsibilities:

• Support QA Engineering group activities as assigned.
• Support Qualification/Validation for QC and manufacturing equipment, utilities, and facilities.
• Review GMP system documents (procedures, forms, etc.).
• Assure calibration/maintenance programs, validation plans, qualification protocols, reports, and procedures are appropriate.
• Support investigations with thorough impact assessment, RCA, and CAPA documentation/implementation.
• Ensure compliance with site validation master plan; support facility start-up operations/product transfers.
• Ensure data governance/data integrity compliance.
• Work with Engineering/Facilities/ECQ to meet global regulatory requirements.
• Ensure procedures confirm data appropriateness; review/approve equipment/utility/facility deviations/discrepancies.
• (People manager) Coach and develop direct reports; lead cross-functional alignment.

Qualifications/Required Skills:

• B.S. degree required; 5+ years pharma/related industry experience.
• GMP/Quality and in-depth risk management knowledge.
• Experience creating/using user requirement specs; IQ/OQ/PQ protocols; UAT; equipment/utility/facility qualification.
• Microsoft Office proficiency; CMMS (e.g., Maximo) and EDMS/quality systems (e.g., BMSDocs, Infinity/Valgenesis).
• Strong scientific/technical judgment, report/investigation authoring and critical review, CAPA/RCA knowledge, trend/pattern recognition, cross-functional communication, independent problem-solving.

Benefits (explicitly listed):

• Health coverage; wellbeing support; 401(k) and insurance/disability benefits.
• Paid time off (flexible/unlimited for US exempt; 160 hours vacation + holidays for certain locations).