Vp Quality And Regulatory Affairs - Pharma

Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan is committed to Quality and Compliance in support of our customers. We are currently seeking a dynamic Vice President of Quality and Regulatory Affairs to join our senior management operating team.

The Vice President of Quality and Regulatory Affairs will proactively develop, lead and drive the execution of the Company's assurance and Regulatory strategy from early stages through commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory compliance. The candidate will have overall responsibility for leading the corporate product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality with an emphasis on customer products and expectations.

The successful candidate will possess:

• Undergraduate degree in life sciences, engineering or business with an advanced degree preferred.
• 15 or more years involvement in pharmaceutical Quality and Regulatory compliance.
• Significant work experience in a CMO or sterile manufacturing environment.
• Knowledge and experience with cGMP and other regulatory compliance requirements.
• Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation.
• Proficiency managing people and processes.
• Ability to travel approximately 25%, both domestically and internationally.

Candidates who desire a rewarding work environment, building processes and motivating teams are encouraged to apply. Relocation will be considered.