Director, Product Quality Leader – PQL

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

📋 Description

• Act as a technical quality authority for one or more products throughout the clinical development process.

• Make decisions related to technical quality and serve as the primary point of contact on the CMC team for all quality-related functions.

• Engage in CMC team meetings, offering technical quality insights.

• Collaborate with the CMC Team and the Quality organization to identify, develop, and prioritize long-term product strategies and initiatives.

• Lead the cross-functional Quality Partner Team that supports Quality-related CMC deliverables.

• Own and oversee the product quality risk register to ensure the identification, resolution, mitigation, and escalation of product quality issues.

• Create a phase-appropriate product specification as part of the product control strategy development.

• Interpret and implement relevant regulatory guidelines and directives concerning product quality.

• Provide oversight and monitor commitments made to Health Authorities related to CMC.

• Identify and spearhead cross-portfolio initiatives or improvements.

⛳️ Requirements

• BA/BS in life sciences or a related field is required.

• A minimum of 12 years of experience in Biotechnology, Pharmaceuticals, Medical Devices, or another highly regulated industry; experience in biologics product development and licensure or technical support is preferred.

• Exceptional interpersonal and communication skills.

• Experience in supporting combination products throughout clinical and commercial stages.

• Comprehensive understanding and application of cGMP principles, concepts, practices, and standards.

• Extensive knowledge and experience in Quality related to biologic and chemical processes, drug development, and analytical methods.

• Previous experience in Regulatory, Quality, Compliance, or a combination of technical areas, such as analytical development, manufacturing sciences, and Quality/Regulatory.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.