QA Project Manager - Biopharma

QA Project Manager

This company is one of the worlds leading biopharmaceutical companies. Through acquistions and mergers, this company has expanded rapidly in its short history and as a result of this conitued growth, a new opportunity within this organisation has arisen for a QA Project Manager.

This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors, material suppliers to all applicable standards for GMP and GDP.

The individual may be responsible for, but is not limited to:
Managing priorities and tasks at Contract Manufacturer.
Leading and monitoring the daily operations at the Contract Manufacturer.
Leading and performing batch review and QA disposition.
Designing, Implementing and improving quality systems and metrics.
Reviewing and approving; batch records, specifications, deviations, change controls.
Leading investigations.
Facilitating technology transfer, process scale-up and process improvement projects.
Leading meetings of suppliers.
Building authentic relationships with Contract Manufacturing.
Leading audits.
Maintenance of all relevant Technical Quality Agreements (TQAs).
Leading Product Complaints and Recall.
Leading and assisting in regulatory agency inspections.
Supporting the Product Quality Review.

Leading training
Minimum Bachelor’s degree in pharmacy, chemistry, biology or a related discipline.
Extensive experience working in a QA role.
Significant experience working in biopharmaceutical industry.
Thorough understanding of quality systems, cGMPs, GDPs.
Experience with Aseptic/ Sterile Processing.
Excellent interpersonal skills and professional skills to interact with contractors while representing the company.
Must be flexible and comfortable with ambiguity in a “start up” environment.
Must be able to prioritize and multitask in an environment with changing priorities.
Must be able to travel up to 50 %.