Senior Manager, Product Development Quality Assurance (CMC Product Lead) - Remote

Overview

The Senior Manager is responsible for ensuring the timely release of GMP clinical supplies by overseeing the quality of the supply chain and collaborating with interdisciplinary product development teams.

In Short

• QA representative for CMC product development teams.
• Provide oversight for the RDQA QA organization.
• Lead complex global cross-functional process improvement teams.
• Offer innovative solutions to complex technical problems.
• Support regulatory inspections and audits.
• Manage clinical supply product actions and stock recovery.
• Conduct onboarding of new assets.
• Perform due diligence of potential assets.
• Ensure quality agreements are in place with partners.
• Influence decision making at senior leadership levels.

Requirements

• Bachelor's in life sciences or equivalent experience.
• Master’s degree preferred.
• 8+ years of experience in Quality Assurance or related fields.
• Understanding of pharmaceutical manufacturing processes.
• Knowledge of global GMP requirements.
• Experience with investigational products preferred.
• Project management experience; PMP certification preferred.
• Strong leadership and communication skills.
• Ability to solve complex quality issues.
• Team-oriented work style.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation, holidays, and sick leave.
• Participation in short-term and long-term incentive programs.