Manager, Quality Assurance Operations

Location
Redwood City, California
Posted
Mar 20, 2018
Required Education
Bachelors Degree
Position Type
Full time

Manager, Quality Assurance Operations

ARMO is seeking a Manager, Quality Assurance Operations who will be responsible for working with the Technical Operations/CMC Department, CMOs and CTLs as a Quality Assurance representative.

Responsibilities and Job Functions

  • Coordinate and facilitate Quality Assurance activities related to production at CMOs.
  • Ensure timely review of production records, procedures and labels.
  • Ensure timely assessment and closure of discrepancies, deviations and change controls.
  • Review batch-related documentation and ensure resolution of issues related to disposition.
  • Communicate lot disposition pending issues to management.
  • Support approval and timely delivery of drug substance and drug product.
  • Ensure products are manufactured in compliance with regulatory and cGMP guidelines.
  • Review and approve manufacturing production records.
  • Review and approve manufacturing and validation documents for regulatory compliance.
  • Compile and verify all batch-related documents into a final product lot disposition package.
  • Provide Quality Assurance support resolving material, drug substance, drug product, environmental, facility and equipment manufacturing issues.
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
  • Gather metric information for use in continuous improvement of areas of responsibility.
  • Report to management as needed.
  • Perform other duties as required.

Knowledge, Experience and Skills:

  • Bachelor’s degree in Biological Sciences or related field.
  • Minimum of 5 years of quality and/or manufacturing experience in a pharmaceutical, biotech, or biologics operation.
  • Working knowledge of quality systems and ability to apply cGMP's in conformance to U.S. and EU standards.
  • Ability to effectively negotiate and build collaboration amongst individuals.
  • Strong interpersonal, verbal and written communication skills.
  • Experience with manufacturing investigations, deviations, and CAPA.
  • Experience with change control practices and strategies.
  • General knowledge of aseptic manufacturing processes.
  • Knowledge of equipment, facility, and utility IQ/OQ/PQ.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.

About

Being a member of the ARMO BioSciences team is a unique opportunity to make a difference in the life of patients suffering of grievous diseases.  We demonstrate a strong sense of personal ownership in everything we do and as such expect honesty, integrity, passion and scientific excellence from our employees. ARMO BioSciences is an equal opportunity employer. We are committed to building a workforce that respects individual skills and diversity and commitment to teamwork. We hire outstanding people and subscribe to a rigorous, fast-paced work ethic where the science leads the business.