Job Description

Executive Director - Permanent - Philadelphia, PA

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

Proclinical is seeking an Executive Director for Quality Control Operations in the gene therapy and pharmaceuticals sector.

Primary Responsibilities:

The successful candidate will focus on leading a team responsible for the testing and release of drug products and iPBMCs. You will oversee environmental monitoring, in-process, final release, and stability testing, ensuring all activities are efficient and compliant with regulations. This position requires strategic thinking and collaboration within a fast-paced environment.

Skills & Requirements:

• Extensive leadership experience in commercial QC roles within the Pharmaceutical/Biotechnology industry.
• Strong preference for cell therapy experience.
• Proactive, results-oriented, and confident self-starter.
• Experience overseeing US and EU commercial manufacturing.
• Expert knowledge of Health Authority expectations and industry practices in the US and Europe.
• Familiarity with FDA and ICH GxP regulations and guidelines.
• Effective negotiation, communication, listening, and writing skills.
• Ability to develop collaborative relationships with diverse stakeholders, including C-Suite.
• Strong scientific and technical expertise to analyze complex data.
• Proven ability to attract and retain top talent and create high-performing teams.

The Executive Director responsibilities will be:

• Represent Quality Control on the Senior Leadership Team to guide site objectives.
• Coordinate and execute lot testing and release activities efficiently.
• Meet and track QC quality record requirements and targets.
• Organize, supervise, and staff reporting functions, expediting decision-making as needed.
• Oversee method transfer, qualification, validation, and training for products.
• Provide technical direction and align problem-solving efforts across functions.
• Contribute to strategic and tactical decisions based on quality principles and data.
• Cultivate a culture of quality and shared accountability for compliance.
• Drive corporate and department objectives through collaboration with colleagues and vendors.
• Prepare facilities for inspections by state, regional, or country authorities.
• Participate in Quality Management Reviews and other performance-driven meetings.

Compensation:

$250 000.00 - $280 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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