Director, Technical Quality Assurance — Biotech (Remote)

Solid Biosciences; Boston (MA); On-site; USD 190,000 - 230,000; Full time

Benefits offered by this job

Health and Dental

401(k) with match

Employee Stock Purchase Plan

Onsite Gym

Lunch delivery

PTO 15 days

Job summary

Solid Biosciences is seeking an Associate Director/Director of Technical Quality Assurance to lead external partners across manufacturing, testing and distribution to ensure compliance with global cGMP and regulatory requirements.

Role reports to the Sr. Director, Technical Quality and supports EU/UK and US distribution, with remote US work options and potential on-site collaboration at headquarters in Charlestown, MA.

Qualifications

• Bachelor’s degree in a science-related field; experience can substitute for degree.
• Minimum ten years in biotech QA; leadership of outsourced activities preferred.
• Strong knowledge of GMP for material sourcing, analytics, labeling and distribution.

Responsibilities

• Oversee CDMO/CTL oversight, audits, and quality agreements.
• Lead QA activities across outsourcing, tech transfer, and GMP manufacture.
• Inspect and approve batch release and distribution compliance.
• Act as QA lead for regulatory submissions and inspections.

Skills

Quality Assurance

GMP Compliance

Leadership

CDMO/CTL Oversight

Regulatory Submissions

Education

Bachelor's degree in science

Job description

Solid Biosciences is seeking an Associate Director/Director of Technical Quality Assurance to lead external partners across manufacturing, testing and distribution to ensure compliance with global cGMP and regulatory requirements.

Role reports to the Sr. Director, Technical Quality and supports EU/UK and US distribution, with remote US work options and potential on-site collaboration at headquarters in Charlestown, MA.