Director, Product Quality Lead

📋 Description

• Play a pivotal role in promoting global quality initiatives.

• Contribute to quality risk management, strategies for knowledge-sharing, and technical training programs.

• Facilitate cross-functional collaboration and encourage continuous improvement.

• Ensure adherence to regulatory standards and foster a strong culture of knowledge sharing.

• Act as a Subject Matter Expert (SME) and Facilitator for quality risk assessments and investigations.

• Oversee Product Quality Network teams responsible for several late-phase clinical or commercial programs.

• Work in partnership with R&D, manufacturing (CMC), and regulatory teams to address quality considerations in new product development.

• Provide guidance on CMC strategies and quality risk management for commercialization efforts.

• Assist in monitoring product quality performance and identifying emerging trends.

• Support the creation and implementation of Quality Risk Management (QRM) frameworks.

⛳️ Requirements

• Bachelor’s degree with over 8 years of experience in quality sciences, quality systems, or similar fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).

• A Master’s degree with at least 10 years of experience is preferred.

• Proficient in computer skills, particularly MS Office (Outlook, Word, Excel, PowerPoint).

• Experience with statistical modeling software (Minitab, JMP, Tableau, SciLab).

• Advanced degree in life sciences, quality management, or a related discipline.

• Extensive background in leading quality investigations, managing quality risks, and implementing innovative technologies.

• Strong knowledge of quality systems, regulatory requirements (e.g., FDA, EMA), and risk management frameworks (e.g., ICH Q9).

• Excellent leadership and problem-solving abilities.

• Experience in creating and delivering global training programs and building SME networks.

• Capacity to convey complex information clearly and effectively across various business functions.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness