Job Title: Senior Commercial and Quality Director
About the Role:
The Senior Commercial and Quality Director will lead the Commercial and Batch Disposition teams to achieve excellence in all aspects of their work. This includes driving clear quality and business objectives, ensuring timely monitoring of batch release performance and progress against defined goals.
Key Responsibilities:
- Lead, motivate and guide the Commercial and Batch Disposition teams to achieve excellence in all aspects of their work.
- Drive and establish a clear quality and business objectives, ensuring timely monitoring of batch release performance and progress against defined goals.
- Lead the PQ Commercial and batch disposition team in the global expansion efforts and the successful launch of new products, fostering innovation and operational readiness and also partner with the commercial manufacturing team in TechOps in the global expansion efforts and the successful launch of new products.
- Drive the commercial and batch disposition team in maintaining the Marketing Authorization Holder (MAH) and (MIA) compliance and readiness for regulatory inspections.
Requirements:
- Collaborative leadership and team player.
- Ability to effectively lead, motivate and coach the team on quality and key business priorities.
- Excellent organizational and interpersonal skills.
- Excellent stakeholder management skills.
- Strong analytical and problem solving skills.
- Solid scientific writing and reporting skills.
- Extensive knowledge and experience in GMP area within a biopharmaceutical company.
- Extensive knowledge of Health authority regulations such as the FDA, EU and PMDA and ICH Guidelines and strong business knowledge of the major markets (US, EU, Japan, etc).