Vice President, Global Quality

Key Responsibilities

• Design and execute global quality strategies from end to end
• Collaborate with internal functions and align goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices
• Direct and oversee the quality planning and execution processes
• Ensure that the quality policy and objectives are understood, implemented and maintained at all levels of the organization
• Assure that the appropriate suite of Standard Operating Procedures is in place and optimally maintained to support critical drug development activities as well as our vendor relationships with external CRO or CMOs
• Ensure quality systems and processes are designed to be appropriate for development, manufacture, testing and release, and distribution of quality product, and be consistent with the global quality strategy and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards and guidances
• Ensures a robust and risk-based audit program is successfully realized throughout our vendor network
• Negotiates, develops and realizes the appropriate development and management of value-added quality agreements with our CMO’s, CRO’s, partners and suppliers
• Develop key quality system metrics and process indicators to proactively identify and address quality systems or product issues
• Lead Quality Management Review and assure that there are no significant interruptions to the business due to quality or compliance issues
• Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes and appropriately structured quality operations
• Interface directly with the FDA, EMEA, and other regulatory authorities and ensure the company is appropriately represented in communications with the health authorities
• Further build and develop a high performing Quality organization and lead team members’ development

Required Qualifications

• Minimum of 15+ years quality experience in a biotech/pharma environment
• Multidiscipline expertise and experience in a GCP and GMP as well as familiarity with non-Clinical requirements and responsibilities
• Excellent working knowledge, understanding and experience with the practical implementation of FDA and EMEA regulations and guidelines in GLP, GCP and GXP environments
• Experience with cGMP requirements for clinical and commercial products and with the US and international regulatory authority inspection requirements and first-hand experience hosting regulatory inspections
• Experience leading a quality team at a company developing small molecule therapeutics
• Successful history of contributing to NDA submissions for novel products
• Established leader in the pharmaceutical industry with clear and proven capability developing ,communicating, leading, managing and inspiring within and beyond Quality organizations and efforts
• Excellent oral and written communication skills to all employment levels, Board of Directors and external partners, suppliers and industry organizations
• Proven experience in leading a highly performing quality team

Education

• Bachelor’s degree or advanced degree (preferred) in a related field