QA Audit Manager

Job Description

We were formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. We aspire to be a patient focused, research based organization that strives to launch treatments which are accessible to patients that need them.

The Quality Assurance Audit Manager will be responsible for the vendor management program, including GMP/GCP audits of contracted organizations. Responsibilities include hosting or assisting with client audits and regulatory inspections managing the vendor qualification and oversight programs, conducting/managing audits of vendors including CMOs (drug product, API and raw material), CROs, contract packagers, contract laboratories, and distributors. Processes audited include sterile production, biotech manufacturing, solid oral dose and ointment manufacturing. This position may assist with product disposition and quality agreements, as needed, as well as a review of investigations and improving/creating SOPs to support the vendor management

process. This is an on-site position. This position reports directly to the Senior Director of Quality Assurance. There are no direct reports under this position.

Vendor Management Responsibilities (Primary):

Own the vendor management process

Manage audit schedules, perform GxP audits (domestic and international), write audit reports and manage responses

Manage the Vendor List and Approved Vendor List o Perform audit report reviews and approve audit reports by 3rd party auditors o Support client audits and regulatory inspections as host or direct support

Quality Assurance Responsibilities (Secondary):

Review of batch records/product disposition, as needed

Review of deviations/OOS/ complaint investigations/ change controls, as needed

Review or author/update SOPs o Assist with the review of other supporting documentation o Author/assist with Quality Agreements o Internal Audits

Assist with Regulatory Agency inspections/Marketing Partner audits

Highly organized with great attention to detail

Strong computer skills, including MS Office (Word, Excel, PowerPoint); SharePoint

Strong knowledge of global regulations for commercial & clinical operations •

Travel approximately 10-20% both domestic and international

Perform additional duties as assigned by department management

7 years experience in Pharmaceutical Quality Assurance required

5 years experience performing GMP audits required

Experience with GMP & GCP audits preferred

Bachelor’s Degree from accredited university

ASQ Quality Auditor Certification preferred

Company Description

Growing and growing, and manufacturing the most generic drugs worldwide.

Full-time