Associate Director, Product Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, execute, and enhance a Quality Management System that aligns with the company's growth stage and product development pipeline.

• Provide oversight for GxP compliance across internal operations and external partners, including CDMOs, CROs, and testing laboratories.

• Ensure effective supplier management and comprehensive audit programs.

• Direct Quality function activities, encompassing deviations, CAPAs, change control, document management, and training initiatives.

• Act as the quality lead for regulatory submissions, including INDs, CTAs, and NDAs, as well as clinical trial material releases and validation initiatives.

• Contribute quality insights for technology transfers, CMC operations, and scaling strategies.

• Supervise batch record evaluations, product releases, and quality assessments of analytical and manufacturing documentation.

• Prepare the organization for regulatory inspections and third-party audits.

• Function as the primary quality liaison to health authorities.

• Recruit, mentor, and manage a small team of QA specialists.

• Promote cross-functional communication and cultivate a culture of accountability.

• Undertake additional responsibilities as assigned.

• Assist in establishing and leading the quality function to ensure compliance with GxP regulations and support product development and commercialization objectives.

⛳️ Requirements

• Bachelor’s degree or higher in Life Sciences, Chemistry, Pharmacy, or a related discipline.

• Over 8 years of experience in pharmaceutical quality positions, with at least 3 years in a leadership role.

• Experience with document control systems, such as ZenQMS, Veeva Vault, or MasterControl.

• In-depth understanding of GxP regulations, including FDA, EMA, and ICH, along with quality best practices throughout the product lifecycle.

• Knowledge of various dosage forms and CDMO-based manufacturing processes.

• Demonstrated capability to function effectively in a resource-limited, dynamic environment.

• Exceptional leadership, communication, and cross-functional collaboration abilities.

• Capacity to balance compliance requirements with operational efficiency.

• Prior experience with successful regulatory submissions and inspections is advantageous.

• Preference for candidates with early-stage development or startup experience.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Paid vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Additional time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.

• Occasional travel up to 20% may be required.