Director of Quality Control

R&D · Seattle, Washington
Department R&D
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor
Compensation Starting at $170,000

Job Description

AltPep Corporation is a biomedical start-up located in Seattle, Washington, with a breakthrough approach for diagnosing and treating some of the world’s most intractable conditions:  amyloid diseases.  Our lead programs are focused on Alzheimer’s Disease and Parkinson’s Disease.

We are seeking a highly motivated and experienced Quality Control (QC) Director. This key position will lead the Quality Control function for AltPep’s diagnostics and therapeutic programs, which are currently in early-stage development.

Principal Responsibilities

 

  • Drive strategic decisions, implement processes and manage activities related to QC systems. Build roadmap for the QC function through sound scientific and regulatory knowledge and experience.
  • Work cross-functionally with internal and/or external partners (i.e. CDMOs) to write technical documentation for incoming materials, in-process and finished products, and post-launch monitoring. This includes product specifications, SOPs, test-methods, qualification protocols/reports, and method transfer protocols/reports, as required.
  • Oversee stability studies and shelf-life programs including authoring shelf-life reports.
  • Serve as QC Subject Matter Expert (SME) for analytical methods, sampling, troubleshooting, investigations, deviations, non-conformances, etc.
  • Work with other SMEs (internal and/or external) to review and author application sections of regulatory submissions, and to provide support for information requests, as required.
  • Work with Quality Assurance and Regulatory to establish and sustain an effective and efficient quality management system.

 

Education and Experience

 

  • in chemistry, biochemistry, pharmaceutical sciences, bioengineering, or related discipline
  • At least 5 years QC management experience and 10+ years industry experience in analytical development and/or quality control (CDMO experience preferred).
  • In depth knowledge of therapeutics and/or diagnostics raw material release and stability testing, methods, and quality systems.
  • Strong working knowledge of CLIA, cGMP, GLP, and FDA guidance and regulations related to diagnostics and/or therapeutics.

 

Required Skills and Abilities

  • Ability to work cross-functionally, both internally and externally, to advance company goals and initiatives.
  • Strong technical acumen, including proficiency at determining the root cause of a problem, and working with others to implement solutions.
  • Ability to articulate information in a logical and clear manner to internal and external teams.
  • Strong technical writing skills.
  • Comfortable in a fast-paced small company environment and able to balance workload based upon changing priorities.

Thank You

Your application was submitted successfully.

  • Location
    Seattle, Washington
  • Department
    R&D
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor
  • Compensation
    Starting at $170,000