Senior Director, Quality Assurance

Job Description 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.

Primary

Activities:

The position will require an in-depth close collaboration with the vendor quality and technical personnel and associated interaction with their functional equivalents in the specific source area on executing against strategic objectives related to the designated vendor base. This will also include navigating technically highly complex quality related matters, both process improvements and significant quality issues and events.  Supervise a group of ~9 Quality professionals.

An advanced level of knowledge of the clinical development process and of the associated stakeholder organizations is required for this role in addition to technical and quality expertise and experience to enable the incumbent to carry the necessary level of credibility to the stakeholder areas as well as with the vendors at senior levels to be  addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

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.

Provide close support to our Company’s Global Auditing group in relation to audits conducted and mitigation activities in regard to audit observations for the designated vendor base.

Interacting cross-functionally and cross-divisionally with senior management on quality/regulatory matters as well as special projects, and externally with inspectors and colleagues in industry in relation to the designated vendor base.

Driving the resolution of contractor / vendor related business practice, Quality and/ or compliance issues of high-impact scope and highest level of complexity on cross-functional and/ or cross-divisional basis in relation to the designated vendor base.

Provision of in-depth technical / quality expertise re; identification of trends and/or potential compliance gaps and proactively leading the resolution of long-standing or significant issues affecting quality and efficiency.

Where appropriate, coaching, mentoring and developing team members supporting their personal development and also colleagues in areas of expertise

Skills:

Primary skills include but are not limited to:

Strong scientific/ technical expertise in R&D activities, coupled with the ability to interact with and influence scientific subject matter experts and senior leaders on various product initiatives and issues.

Strong compliance knowledge and understanding of regulatory agency regulations and requirements and interpretation and application re; GMPs to a R&D environment.

Possess deep drug development knowledge; demonstrated ability to facilitate training and learning with colleagues and apply knowledge to enhance the drug development process.

Demonstrated knowledge of continuous improvement methodologies; ability to direct complex cross-functional initiatives.

Demonstrated…