Senior Director, Quality Control

Scorpion Therapeutics; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

CG Oncology seeks a Senior Director of Quality Control to oversee product quality and regulatory compliance across bladder cancer therapies from clinical to commercial stages. You will drive quality strategy and ensure GxP adherence in a global, multi-site setting.

Lead analytical and manufacturing quality systems, support process validation and tech transfer, and steer CAPA and risk management while building and mentoring a high-performing QC team with influence across the organization.

Qualifications

• Bachelor's or Master’s degree in Life Sciences.
• 10+ years in biopharma quality roles.
• 5+ years in senior leadership.
• Extensive GxP experience with biologics development, late-stage manufacturing, and regulatory submissions.
• Hands-on with batch release, deviations, and change control.
• Proven leadership in matrix environments.

Responsibilities

• Establish and lead global quality strategies.
• Ensure regulatory and GxP adherence.
• Oversee analytical and manufacturing quality systems.
• Support process validation and technology transfer.
• Lead CAPA and risk management initiatives.
• Build and mentor QC teams.

Skills

Quality leadership

GxP experience

Regulatory submissions

Quality systems

Education

Bachelor's or Master’s in Life Sciences

Job description

Role: Senior Director of Quality Control overseeing product quality and compliance across CG Oncology’s bladder cancer therapies from clinical to commercial phases.

Responsibilities: establish and lead global quality strategies, ensure regulatory and GxP adherence, oversee analytical and manufacturing quality systems, support process validation and technology transfer, lead CAPA and risk management initiatives, and build/mentor QC teams.

Requirements: Bachelor's or Master’s in Life Sciences; 10+ years in biopharma quality roles, including 5+ years in senior leadership; extensive GxP experience with biologics development, late-stage manufacturing, and regulatory submissions; hands‑on expertise with quality systems such as batch release, deviations, and change control; proven leadership in matrix environments.

Preferred: experience in biologics manufacturing, BLA submissions, and global inspection readiness; strong regulatory engagement skills; up to 20% travel.

HighValue: biologics, biologics manufacturing, late-stage development, BLA, GxP, product lifecycle oversight, regulatory compliance, international collaboration, remote work option.