Associate Director, Quality Control Compliance

Scorpion Therapeutics; Hopewell (NJ); On-site; USD 180,000 - 230,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of QC Compliance to oversee GMP lab compliance for large and small molecule manufacturing at the Hopewell, NJ site. The role leads QC programs, investigations and regulatory documentation, while guiding a small team and collaborating across QA, Regulatory and Manufacturing to ensure adherence.

On-site work in Hopewell with travel ~20% may be required. A strong background in cGMP for large molecules and EU GMP is essential, with 8+ years in

Qualifications

• Bachelor's degree with 8+ years in FDA-regulated biotech/pharma environment.
• 5+ years of managerial experience.
• Extensive knowledge of cGMP/EU GMP for large molecules.
• Strong leadership, analytical, and communication skills.

Responsibilities

• Develop and implement QC compliance programs.
• Lead investigations for OOS/OOT/OOE results.
• Prepare compliance documentation.
• Manage internal and external GMP audits.
• Collaborate with QA, Regulatory, Manufacturing and other departments to ensure regulatory adherence.
• Foster a culture of quality and continuous improvement.
• Manage and mentor a team of 1-2 QC compliance professionals.

Skills

Leadership

Analytical

Communication

Regulatory knowledge

Education

Bachelor's degree in biotech/pharma or related field

Master’s degree (preferred)

Tools

Veeva

LIMS

Job description

Associate Director of QC Compliance

overseeing GMP lab compliance for large and small molecule manufacturing at the Hopewell, NJ site.

Responsibilities

• develop and implement QC compliance programs
• lead investigations for OOS/OOT/OOE results
• prepare compliance documentation
• manage internal and external GMP audits
• collaborate with QA, Regulatory, Manufacturing, and other departments to ensure regulatory adherence
• and foster a culture of quality and continuous improvement.
• Manage and mentor a team of 1-2 QC compliance professionals, guiding training and performance.

Requirements

• Bachelor's degree with 8+ years in FDA-regulated biotech/pharma environment
• 5+ years of managerial experience
• extensive knowledge of cGMP/EU GMP for large molecules
• strong leadership
• analytical
• and communication skills

Preferred

• Master’s degree
• experience with Veeva and LIMS
• and previous compliance leadership.

HighValue

• GMP compliance
• laboratory investigations
• deviation management
• regulatory documentation
• large molecule manufacturing
• cGMP standards
• FDA/EU regulations
• leadership in a biotech setting.

WorkSetup

• on-site in Hopewell, NJ; travel approximately 20%.