Global Leadership Role in Quality Operations
The Global Head of Quality Operations, Biologics will be responsible for providing technical quality and regulatory expertise to the Biologics site network.
This role will support the development and execution of the Biologics Quality strategy, ensuring alignment with customer needs and business unit strategies.
The incumbent will ensure compliance with GxP standards, corporate policies, and regulatory body guidelines.
Key Responsibilities:
* Provides leadership for quality and regulatory activities across the Biologics network
* Plans, directs, and controls all quality requirements and leads a team of DPS Quality Site Heads
* Hires and develops top talent to create high-performing teams and succession pipelines
* Ensures active training and development plans for quality staff
* First point of contact for Biologics sites for any quality and regulatory topics
Requirements:
* Master's Degree or equivalent experience - Quality Management or related science discipline
* Relevant experience in regulated pharmaceutical industry, including manufacturing, quality assurance, quality control, R&D, and/or drug regulatory affairs
* Experience in chemical and biological GMP API manufacturing, with demonstrated ability to interpret and implement quality and regulatory requirements in a cGMP environment