Head of Quality (CD20-234)

Catalyst Biosciences is seeking an accomplished individual to serve as the Head of Quality reporting to the Senior Vice President, Regulatory Affairs. The successful candidate will be a proven leader who will work closely with the company’s leadership team and company staff to develop and advance Catalyst Biosciences’ pipeline programs consistent with the company’s vision and in a manner compliant to quality regulations.

The Head of Quality is a hands-on position responsible for driving the company’s quality function with a focus on Quality Systems and Quality Operations. This person will interact with internal departments to build and direct the corporation’s quality initiatives. In addition, this person will ensure adherence to quality standards for CMC activities performed at external contract manufacturing organizations and represent the company’s quality function during interactions with health authorities.

ABOUT CATALYST BIOSCIENCES

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late stage clinical trials with the intent of commercialization.

Responsibilities:

  • Accountable for developing, articulating, and gaining alignment across the organization on the necessary internal quality policies, processes, and procedures that support advancement of the company’s pipeline in a manner compliant with governing regulations
  • Lead and direct the overall activities required to ensure key quality systems are developed and implemented, including a document control system/process, GxP training, and CAPA system
  • In the context of an outsourcing model, oversee a regulatory compliant quality operations function for the company, including CMC change control, review/acceptance of product production and release testing records, product disposition, and setting of product retest/expiry dating
  • Collaborate/support clinical-regulatory compliance activities
  • Actively collaborate with development teams and functional areas to ensure quality standards are met
  • Ensures product manufacture, testing, and disposition are compliant to documentation filed with regulatory authorities
  • Direct the activities of subordinates to establish and maintain a high level of excellence regarding adherence to quality standards and scientific integrity
  • Coordinate with internal functional areas and external contract manufacturing organizations to represent the company during interactions with health authorities on quality matters
  • Develop and implement a process for presentation of periodic quality status reports to the company’s leadership team
  • Lead, manage, and ensure a state of inspection readiness on CMC matters
  • Proactively provide strategic input on development/commercialization efforts from a quality point of view
  • Leads the Quality Risk Management activities related to CMC
  • Actively support the company’s cultural initiatives

Qualifications:

  • Minimum of 10 years of quality experience in biotechnology with an emphasis on an outsourcing model
  • BS degree in Chemistry, Pharmaceutical Science, Microbiology, or related scientific field preferred
  • Comprehensive understanding of cGMP and quality systems applicable to pharmaceutical development and commercialization
  • Proven track record in building and managing a high performing quality team
  • Must be a dynamic leader with outstanding communication skills and an ability to effectively direct subordinates
  • Demonstrated strengths in problem solving, strategic planning, and working collaboratively

 

Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to jobs@catbio.com, referencing requisition number (CD20-234) in the subject line.