Manager, Product Quality

About the role

Manager of Product Quality will oversee product quality activities across development and commercial-stage products, ensuring quality performance, compliance, and continuous improvement throughout the product lifecycle.

Responsibilities

• Serve as Product Quality Lead for assigned program(s)
• Investigate and finalize reporting activities for potential product complaints
• Support Clinical Operations as required in the evaluation of product temperature excursions
• Support manufacturing campaigns and release activities
• Ensure archival for expedient retrieval of key manufacturing documentation
• Review deviations, investigations, CAPAs, and change controls for adequacy
• Analyze and report on product quality trends
• Facilitate the development of risk assessments and mitigation activities and perform routine risk monitoring activities
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions
• Support inspections and audits

Basic Requirements

• BS/MS in Life Sciences
• 5-10 years pharmaceutical quality experience
• Knowledge of GMP manufacturing and quality systems

Additional Preferences

• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear
• Leverage technical depth and a growth mindset to make impact; imagine what's possible and pursue it with intention and energy
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital

Pay

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $169,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)