Vice-President/Sr. Director, Quality Assurance

Company: Protagonist Therapeutics, Inc.
Location: Newark
Posted on: October 19, 2020

Job Description:

The Vice-President/Senior Director of Quality Assurance oversees and directs the Quality Assurance & QC function responsible for driving the company---s QA & QC strategy, Quality Management Systems, and policies. The ideal candidate will be responsible to lead Quality Control & Quality Assurance activities, the Quality Management Systems (QMS), assure compliance to USA FDA GXP regulations across products and all regulatory audit and inspection activities. This position will be responsible for translating the company---s quality strategy into SOPs, tactical policies, processes, and procedures to ensure 100% compliance with meeting global regulatory standards. This role will manage internal Quality Assurance professional staff and/or consultants and directs and implements advancement of Protagonist---s Quality Systems. Responsibilities: Lead the Quality Assurance department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as PTGX is transitioning from discovery through clinical development to launch readiness. Provide leadership and direction for the development and implementation of robust Quality Systems. Develop corporate and/or other organizational polices related to GXP compliance and oversee their implementation, including quality standards and SOPs. Implement governance plan to ensure good communication and decision making at the appropriate levels for quality related topics. Develop proactive approaches and provide strategic direction to implement quality standards and procedures for GXP regulatory compliance to meet company needs. Develop and manage the team overseeing quality and GXP compliance. Oversee the planning and conduct of internal and external audits to ensure compliance with GCP regulatory requirements for clinical trials and GMP regulatory requirements for investigational and commercial drug manufacturing, and ensure corrective actions are implemented to resolve audit findings. Manage internal and regulatory agency inspections. Develop and manage relationships with senior Quality representatives from partners, vendors, and collaborators. Provide quality assessment for potential in-licensed compounds and/or development collaborations. Keep current on changes in industry and regulatory standards for GXP requirements and advise on business impact. Indirectly supervises employee(s) through a dotted line matrix structure or via other subordinate supervisors. Professional Experience / Skills: Bachelor, Master or PhD degree in Engineering, Life Sciences or similar fields related disciplines and 15 years of related work experience, or Equivalent combination of education and experience. Experience in sterile product manufacturing, biologics or peptides will be a plus. At least 10 years of experience in positions of substantial management responsibility within Quality Assurance. Substantial experience in leading and participating in regulatory inspections and preparing staff for regulatory inspections. Attention to detail with an ability to perform critical review of various types of documents. Experience with documentation systems, document review and auditing responsibilities. Demonstrated ability in setting successful quality strategies and building and leading the function. Thorough understanding of industry regulatory environment related to quality systems. Ability to evaluate complex situations and to render judgments where significant legal, financial, and regulatory risks exist, and compliance guidelines are vague or not available. Strong organizational skills and the ability to participate effectively on cross-functional teams and across business unit lines. Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment. Superb interpersonal, written communication and oral presentation skills.

Keywords: Protagonist Therapeutics, Inc., Newark , Vice-President/Sr. Director, Quality Assurance, Executive , Newark, California