Senior Director, Quality Assurance

The Senior Director, Biologics, DP, & Device Platform Lead, Third Party Quality Management & Due Diligence (TPQM & DD), Global Development Quality is responsible for providing expert strategic, scientific and operational leadership to teams.

This position will lead strategic operational initiatives, build talent across the organization, and the overall operational and strategic oversight of third-party contractors and vendors providing biologic drug substance, sterile and non-sterile bulk drug product, and medical device and combination product including design and assembly in support of our Company's clinical supply chain.

This position is responsible for a team of >9 professionals. Key areas of responsibility include defining and driving the quality performance and ensuring compliance robustness on behalf of TPQM across a designated vendor base. This includes supporting the development and execution of a strategic global vision for TPQM and influencing the same for key stakeholder in multiple business areas.

This role will provide specific quality support and be responsible for supporting the development and driving the execution of the continuous improvement of third-party quality processes within a high-impact vendor base to minimize and mitigate risk to our Company development programs.

• Execute the daily operational TPQM support for the biologics drug substance and sterile and non-sterile drug product vendor bases related to the most complex activities that our Company outsources, with the associated potential for high impact to the development portfolio.
• Supporting the development of and driving the execution of quality strategies, improvement initiatives in line with business drivers and objectives.