POSITION OBJECTIVE:         The Director of Quality Assurance serves as the leader of all Quality Assurance activities for oversight of GMP manufacturing and testing for Athenex’s US Contract Manufacturing Organizations. Will provide guidance on challenging quality related issues, oversee all regulatory and customer audits and leads with the division staff on strategic projects. Communicates quality issues to Regulatory Authorities. Responsible for overseeing the Supplier Qualification, Quality Agreement, and Product Launch Processes for APD. Will also be responsible for managing the development and adherence to all quality management systems, development and implementation of quality metrics as well as fostering strong working relationships between Quality, Operations, Regulatory Affairs and Medical Affairs.  


REPORTS TO:                        Vice President of Global Quality Assurance

 

MANAGES:                             APD Quality Team and Systems Personnel

 

 

Essential Job Functions/Responsibilities

·        Develops and executes a quality assurance road map that includes resource requirements (including technical solutions, human capital, CapEx, training, etc.) to meet operational business initiatives. 

·        Support compliant systems for all commercial contracted manufacturing and testing operations.

·        Oversees Product Quality Complaint and Adverse Event system, change control system and electronic Quality Management System

·        Oversees Supplier Qualification, Quality Agreement and Product Launch systems for APD

·        Development, implementation, and maintenance of quality improvements, including quality systems and documentation.

·        Responsible for generating documentation and communicating quality issues to FDA and other Regulatory Agencies including submission of Field Alert Reports and Recall documentation.

·        Acts as Quality lead for Contract Manufacturing relationships.

·        Improves and enhances quality standards and strategies to meet both regional and international requirements alongside team members.

·        Involved in the disposition of all quality related issues as they impact manufactured product, utilized raw materials and analytical testing to assure released products possess the required potency, purity, and conformance to established specifications.

·        Ensures products meet the necessary regulatory registrations in accordance with state, federal and global requirements.

·        Hosts site visits from customers and regulatory bodies for the purposes of auditing/inspecting site compliance. Develops responses and corrective actions based on relevant audit observations and engages site subject matter experts for support.

·        Develops and maintains a system for reporting Contract Manufacturing and Internal Quality metrics and Management Review in accordance with regulatory and site management requirements. Manages Annual Product Review process for APD products. Drives discussion with Quality Review Board for establishing a roadmap for strategic quality improvements and priorities.

·        Promotes and implements training, motivation, mentorship, and career development opportunities for quality team members. 

·        May perform other duties as assigned

 

Required Education & Experience

  • 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 12 years of experience in progressive Quality Assurance and/or Quality Control roles in the pharmaceutical organization
  • Minimum of 5 years of experience leading Quality teams of a pharmaceutical organization
  • Strong experience with and knowledge of cGMP, GLP and GCP Quality Management Systems, including 21 CFR 210/211/820 Quality Systems and knowledge of Global Quality regulations
  • Direct and positive experience in communicating with regulatory authorities, customers, and executive leadership.
  • Experience in sterile drug product manufacturing is strongly preferred.
  • Experience leading CAPAs, investigations, root cause analysis and process improvement.

 

Required Skills & Abilities:

  • Knowledge of both national and international markets (specifically, the US and EU).
  • Strong, dynamic leadership, communication, and presentation skills with the ability to mentor and develop high performing teams

 

Working Conditions:

  •  Must be available for 20% travel – some could be national.


Benefits:

Medical, Dental, Vision, STD/LTD, HSA, 401k, and more!


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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