AltPep Corporation is a biomedical startup based along Seattle’s Lake Union focused on developing early disease-modifying treatments and detection tools for amyloid diseases by targeting one of the earliest molecular triggers – toxic soluble oligomers. These toxic oligomers are associated with many diseases, including neurodegenerative diseases and type 2 diabetes.
AltPep draws its origins to Dr. Valerie Daggett’s lab at the University of Washington’s Bioengineering Department. The company closed a significant round of financing in late 2020 and is currently seeking to expand at its headquarters located on the North end of Lake Union in Seattle.
We are seeking a highly motivated and experienced Director of Quality. This key position will help build and lead the QA/QC function for AltPep’s diagnostics and therapeutic programs, which are currently in early-stage development.
- Assure quality products and processes by establishing and maintaining quality standards within the Quality Management System.
- Author quality assurance procedures to conform to company and industry requirements.
- Manage the implementation, maintenance, and improvement of Quality Systems based on established company direction, development phase, and priorities.
- Lead and perform activities related to: Quality Management Reviews, Internal Audits, Supplier Audits, CAPAs, Deviations, Training, Document Control, Change Control, and Risk Management.
- Compile and report performance indicators, metrics and compliance status of Quality Systems.
- Establish and maintain continuous improvement programs.
- Assist with training on GxP and other quality-related topics.
- Represent Quality Department during regulatory inspections, as needed
- 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.
- 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.
Education and Experience
- Masters (PhD preferred) in chemistry, biochemistry, pharmaceutical sciences, bioengineering, or related discipline
- At least 5 years quality management experience and 10+ years industry experience in analytical development and/or quality (CDMO and/or IVD experience preferred)
- Demonstrated knowledge of regulations related to diagnostics and preferably therapeutics (i.e. GxP, ISO 13585, 21 CRF Part 820, etc.), experience with FDA filings preferred
- In depth knowledge of therapeutics and/or diagnostics raw material release and stability testing, methods, and quality systems.
- Experience establishing and/or managing QMS and quality assurance programs
Required Skills and Abilities
- Excellent written, verbal, and interpersonal communication skills with demonstrated ability to write and summarize quality information, reports, and processes.
- Competency with electronic quality managements systems
- 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.
- Comfortable in a fast-paced small company environment and able to balance workload based upon changing priorities.
AltPep Corporation is a dynamic biomedical startup in Seattle that offers a competitive compensation package, including equity incentives, as well as a benefits program designed to support the well-being of our employees and their families. Benefits include medical, vision and dental coverage, group life insurance, and 401(k). To learn more about us please visit www.altpep.com. AltPep is an equal opportunity employer with the desire for diversity of all types. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, disability, or any other status protected by federal, state, or local law.