Vice President, Quality & Regulatory Affairs

About this opportunity :

The Vice President of Quality Assurance and Regulatory Affairs is a top executive responsible for overseeing all overall quality assurance and regulatory functions for Nitto Avecia and subsidiary companies. The Vice President leads teams responsible for a a broad range of quality assurance work including quality operations, GMP creation and maintenance, regulatory compliance, process validation, vendor management, internal auditing, inspection management, and audit management programs. This position will work closely with the local and global Quality leaders to manage, develop, and implement Quality initiatives throughout the organization. The position leads the strategic development and implementation of quality strategies for the business that maintains Nitto Avecia's leadership an industry leader while ensuring the operation of efficient quality systems. 
 

Key Responsibilities:     

• Ensure compliance with all applicable policies and regulatory requirements
• Exercise broad phased based risk assessment regarding quality policies and practices and implementing effective changes
• Define the company culture appropriate for each entity and ensure that policy, practices, and leadership actions are aligned with that culture
• Understand Nitto’s vision/mission and promote it within organization
• Select and develop quality assurance talent in each entity and ensure that succession candidates exist for each key position
• Successfully and efficiently plan and execute activities necessary to ensure compliance with FDA and other applicable health authorities
• Interface externally with auditors, partners, regulators, and others as a credible, influential, and respected thought leader and company spokesperson
• Establish and promote a quality-driven product development culture in the organization
• Understand relevant industry trends and guide leadership accordingly
• Ensuring the appropriate level of integration between Nitto Avecia sites to efficiently meet customer and regulatory expectations as well as with other Nitto group Quality organizations.
• Acting as "face of Avecia" for quality in the oligonucleotide and small molecules markets that we serve by representing Nitto Avecia while interacting with customers, consultants, regulatory agencies and while participating in industry conferences.

Required Skills/Abilities:

• Bachelor’s degree with 10+ years’ Quality/Regulatory Leadership role in the following type of organizations:
• Contract manufacturing (CMO or CDMO)
• Commercial API or drug substance manufacturing.
• Multi product/multi- phase pharmaceutical manufacturing.
• Experience in the pharmaceutical or biologics experience, with preference given to oligonucleotide experience.
• Significant experience and understanding of GMP and principles of regulatory compliance 
• Experience managing in a global, multicultural organization
• Ability to manager onsite and hybrid quality assurance teams 
• Experience in hosting FDA/EMA audits.
• Regulatory experience with BLAs, NDAs and DMFs.