Manager, QA Operations

What You'll Do

Manage quality assurance lot release activities at the company's contract manufacturing organizations(CMOs). The individual will act as a quality liaison with assigned CMOs, including review of packaging batch records and the issuance of certificates of compliance. The QA Manager will ensure that the CMO SOPs and batch records are in compliance with cGMPs and will serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to packaging CMOs.

Responsibilities

(5-7 bullets max)

• Review and manage master and executed packaging batch records from CMOs

• Review process validation protocols and reports

• Perform quality review of quality events (deviations, product complaints, investigations, change requests, supplier notifications, etc.)

• Manage lot release activities

• Communicate packaging deficiencies/non-conformances to management and work with CMOs to ensure timely resolution

• Represent QA on project teams and participate in monitoring of CMO performance

• Participate as Person-In-Plant, internal and external project team meetings, vendor audit, partner audit and regulatory inspections, as needed

• Write and review SOPs and quality assurance procedures, as needed

Where You'll Work

This is a U.S. based role that will require quarterly, or as needed visits to our San Francisco Office

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

• Bachelors degree in a scientific discipline

• 5+ years of relevant Quality experience (QA or QC) within a biopharmaceutical company, or contract research organization

• Prior experience reviewing packaging master and executed batch records

• Good organizational skills, ability to manage multiple tasks and maintain meticulous attention to detail

• Strong knowledge of global GxP regulations (FDA, EMA, ICH)

• This position requires travel - 10% total time will be used for travel