Vice President Quality Assurance - New Jersey, United States - Skills Alliance

Description

I am exclusively partnered with a client looking to recruit the most senior memeber of their QA team. This is a critical role. I am looking to speak with individuals experienced in biologics - particularly antibodies.

Responsibilities:

• Oversee and manage the quality assurance department, ensuring compliance with all applicable regulations and guidelines, such as cGMP, ICH, and FDA requirements.
• Develop, implement, and maintain robust quality management systems, including quality control procedures, process validation, and continuous improvement initiatives.
• Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs) to ensure the quality and consistency of biologics throughout the product lifecycle.
• Establish and monitor key quality metrics, identify areas for improvement, and implement corrective and preventive actions.
• Provide strategic guidance and leadership in quality-related decision-making, risk management, and quality culture development.

Experience:

• Minimum of 10 years of progressive experience in quality assurance, preferably in the biopharmaceutical or biologics industry.
• Demonstrated expertise in the design, implementation, and management of quality systems for the development, manufacturing, and release of biological products.
• In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of biologics, including FDA, cGMP, and ICH requirements.
• Proven track record of leading and managing a quality assurance team, with a strong focus on continuous improvement and fostering a culture of quality.
• Advanced degree (e.g., MS, PhD) in a relevant scientific or engineering field, or equivalent combination of education and industry experience.