Quality Operations Manager

Menlo Park, CA
Oct 06, 2021
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Job Description:

The Quality Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.

  • Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
  • Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations.
  • Perform review of executed batch records and test data, and perform product dispositions.
  • Review and approval of validation protocols and reports (e.g., process, method, etc.)
  • Lead and support quality audit of suppliers, CLOs, and CMO
  • Perform quality trends analysis and reports, recommending continual improvements opportunities
  • BS or Master’s degree in science, engineering or related field
  • 10 years in the bio/pharmaceutical industry
  • 5-7 years in Quality Assuranc
  • Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products.
Preferred Skills, Qualifications, or Technical Proficiencies:
  • Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes.
  • Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products.
  • Ability to work independently and communicate effectively with project team members and management groups and suppliers.
  • Work well in a project team environment with solid problem analysis and decision-making ability.
  • Ability to lead or support internal and external compliance audits of suppliers, CLOs, and CMOs
  • Ability to work independently in addition to clearly and concisely communicate both in writing and verbal
  • Ability to identify compliance risk and recommend mitigations.
  • Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations.
  • Strong statistical mindset and metric presentation.
  • Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio.