Our client, a global pharmaceutical manufacturer with strong pipeline of products in drug development and commercial manufacturing, now seeks a Director, Quality Assurance Biologics (Development & Commercial Manufacturing) who will work as part of the Development & External Quality function.
This role will provide Quality oversight for the company’s Biologics program for Drug Substance and Drug Product development and commercial manufacturing. This role will report to the Senior Global Director, Q.A. (Development & Commercial Manufacturing).
The Development & External Quality function presents the quality organization in the day to day support and oversight of technical transfer, validation, GMP production and operations at contract manufacturing and packaging including storage and distribution for all clinical and commercial products. In addition, the Development & External Quality function is also responsible for:
- The Vendor Qualification program
- Design Control for Drug — Device Combination Products, including PMSR
- QA oversight and support of GMP Phase 1 production for both small and large molecule drug substance at the company’s US facility
- QA support and oversight for Analytical Development (Global)
The Development & External Quality Function teams are highly mobile due to the external oversight activities, and teams (including the role of Director of Q.A.) hence travel requirement, both domestic and international. This hire will have some flexibility to work from home when not travelling.
- Bachelor degree in Biologics, or related sciences; Master degree preferred
- QP Qualified considered an advantage
- Experience in Biologics, Drug Substance and/or Drug Product is highly desirable.
- Advanced knowledge of relevant regulations and regulatory guidance including US /EU and OUS required to act as a resource for colleagues
- Demonstrated strength in management, written and oral communication, leadership, and project management skills
- Ability to create and cultivate working relationships and networks across the organization, building agreements that lead to mutually beneficial outcomes
- Ability to work in a fast-paced environment with aggressive project timelines
- Able to direct, motivate, support, and develop team members who are fully engaged in pursuing organizational goals and their individual career aspirations
- Able to broadly apply GMP principals to quality assurance issues, systems and goals
- Ability to support regulatory submissions from early stage to commercial launch
- Ability to manage budgets and react appropriately
- Root Cause Analysis Training
- Ability to travel based on business needs up to 50%, international and domestic travel.
For further details, contact Larry on +353 1-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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