Director, Product Quality Leader

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 clinical development and into post-commercialization.

• Make informed technical quality decisions and serve as the primary contact for the CMC team regarding quality functions, risks, and issues.

• Provide leadership in quality for CMC-related strategic initiatives and drive quality-related choices.

• Engage in CMC team meetings and technical discussions, offering expertise for global strategies and implementation plans across the product lifecycle.

• Collaborate with CMC and Quality teams to identify, design, and prioritize long-term product strategies and initiatives.

• Develop product-specific Quality strategies.

• Lead the cross-functional Quality Partner Team and oversee deliverables in line with CMC execution plans.

• Facilitate communication of pertinent information between the Quality Partner Team, CMC Team, and functional managers.

• Own and maintain the product quality risk register, which includes identifying issues, resolving them, mitigating risks, and escalating when necessary.

• Create phase-appropriate product specifications and work together on the Quality Target Product Profile and product control strategy.

• Formulate product comparability protocols and assessments for clinical and commercial products.

• Interpret and implement regulatory guidelines and directives, including 21 CFR, USP, EP, JP, and ICH.

• Review and draft sections for regulatory submissions.

• Review and endorse Annual Product Reviews for commercial programs.

• Supervise and track CMC-related commitments to Health Authorities.

• Support or lead initiatives aimed at enhancing PQL operational efficiency and effectiveness.

• Spearhead cross-portfolio initiatives to mitigate technical quality risks.

⛳️ Requirements

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

• An advanced degree is preferred.

• A minimum of 12 years of experience in Biotech, Pharmaceuticals, Medical Devices, or another highly regulated industry.

• Preferred experience in the development and licensure of biologics products or providing technical support.

• Experience in both clinical and commercial phases of the product lifecycle is highly desirable.

• Experience with combination products through clinical and commercial stages, including device quality considerations, is an advantage.

• Exceptional interpersonal and communication skills.

• Ability to engage with a diverse range of internal and external stakeholders at all organizational levels.

• Proven leadership skills, capable of aligning on, making, and acting on decisions while balancing speed, quality, and risk.

• Experience in influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment.

• Ability to develop relationships that emphasize best-practice sharing and collaborative problem-solving.

• Capability to navigate ambiguity and complexity, continually adapting options and solutions at all organizational levels.

• Results-oriented, adept at managing multiple projects efficiently.

• Excellent written and verbal communication skills; able to effectively convey information to all organizational levels.

• Proficient public speaking skills.

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

• Familiarity with the international regulatory landscape is preferred.

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

• Prior experience in Regulatory, Quality, Compliance, or a blend of technical experiences such as analytical development, manufacturing sciences, and Quality/Regulatory.

• Periodic travel is necessary.

🏝️ Benefits

• Equal Opportunity Employer/Veterans/Disabled.

• An Equal Opportunity Employer.

• Periodic travel is required.