Global senior director of ra/qa

Job Description

Mantell Associates is partnered with a rapidly growing CDMO, who is looking to expand their team with the addition of a Global Senior Director of RA/QA.

Global Senior Director of RA/QA - Responsibilities:

* Develop and implement effective Quality Assurance & Regulatory strategies by maintaining Policy and Intelligence
* Manage and mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies
* Be at the forefront of new and developing regulations and guidelines
* Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval
* Responsible for providing an overview of QA/RA Policy to stakeholders and staff
* Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations
* Ensure submission publishing is well executed and on time
* Engage and support all relevant staff to support M&A activities
* Proactively manage a Regulatory Affairs network externally and internally

Global Senior Director of RA/QA - Requirements:

1. Bachelor's or advanced degree in a scientific or medical field
2. Strong experience within Quality