POSITION OBJECTIVE: As our Senior Director of Corporate Quality, you will provide leadership for Quality Assurance and Quality Control activities to our clinical, R&D, corporate and commercial business segments. You will provide guidance on challenging quality related issues, oversee regulatory compliance and work with senior leadership on the implementation of strategic quality initiatives. You will also be responsible for adherence to all Quality Management Systems administered at the Corporate level.  

Essential Job Functions/Responsibilities

  • Outline and implement a strategic vision for Quality and Compliance at the Corporate level, assembling the systems and leadership team to implement at the site and division level.
  • Support strategic quality initiatives for including buildout of new facilities, integration of new business units and technologies, commercialization of new products, implementation of global software platforms, and critical issue response. 
  • Lead Computerized System Validation programs by supporting the implementation, administration and lifecycle management for critical software platforms utilized companywide, such as the electronic QMS and ERP systems
  • Lead the Supplier Qualification program, ensuring that critical raw materials and contract manufacturing organizations are able to provide a consist supply of materials to support uninterrupted operations from Clinical to Commercial manufacturing.
  • Lead the CMC quality, ensuring compliance and continuous improvement for Clinical Manufacturing from Pre-Clinical operations through Commercialization.
  • Lead manufacturing (Athenex Pharma Solutions) quality operations, ensuring compliance and continuous improvement for 503B and proprietary products. 
  • Quality Control – Stability - Microbiology
  • Lead the Dunkirk manufacturing facility quality operations, ensuring compliant facility design, buildout, staffing, and startup of commercial operations.
  • Manage compliance activities for multiple FDA registered drug establishments
  • Host regulatory inspections and customer visits, ensuring appropriate corrective actions and responses are provided with proper site engagement.
  • Develop and maintain a system for reporting metrics in accordance with regulatory and local management requirements. Drive discussion within Senior Management review to ensure a strong commitment to strategic quality improvements and response to potential compliance issues.
  • Promote and implement staff training, motivation, and career development opportunities for Quality team members.
  • Oversee analytical method development, validation, and technology transfer
  • Must be available for 20% travel – some could be national.
  • Must have a valid driver’s license to travel between local site locations.
  • Other projects as may be assigned.

Required Education & Qualifications

  • Bachelor of Science degree in Biology, Chemistry, or related life science field; advanced degree in life sciences field or MBA is a plus.
  • Minimum of 10 years of experience in progressive Quality Assurance and/or Quality Control roles in the pharmaceutical organization
  • Minimum of 10 years of experience leading the Quality team of a pharmaceutical organization with knowledge of both national and international markets (specifically, the US and EU).
  • Strong experience with and knowledge of cGMP, GLP and GCP Quality Management Systems.
  • Direct and positive experience in communicating with regulatory authorities, customers, and executive leadership.
  • Experience in sterile drug product manufacturing in strongly preferred.
  • Strong, dynamic leadership, communication, and presentation skills with the ability to mentor and develop high performing teams
  • Experience leading CAPAs, investigations, root cause analysis and process improvement.
  • Lean Six Sigma experience with strong project management and leadership.
  • Experience in computerized software validation implementation and lifecycle management.
  • Must be available for 20% travel – some could be national.
  • Must have a valid driver’s license to travel between local site locations.

Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.

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