Quality Excellence Director QA/qs At

The Quality Excellence Director QA/QS, Advanced Therapies Platform, is responsible for delivering the Quality Assurance (QA) and Quality Systems (QS) platform strategy. This role will develop, execute, and monitor Advanced Therapies Quality (ATQ) projects, budget and strategies, and establish robust business and quality processes and systems to monitor progress of initiatives against plans and realization of strategic outcomes.

**Duties & responsibilities**
- Develop, maintain, and execute Advanced Therapies QA/QS projects that forward our strategies to maximize productivity, reduce OOS, improve quality, reduce turnaround time, improve costs, and optimize QA and QS processes across the platform. Ensure that the status of Quality projects is clearly understood by all stakeholders and that the organization is achieving its strategic goals at the optimum pace. Support the ATQ LT in overall management, prioritization, risk monitoring, and course corrections as required. Assist and/or lead in specific projects, as needed;
- Partner effectively with the ATQ Site Quality Heads, above site Quality and JJT teams, and JJRC to facilitate deployment of network wide quality improvement initiatives and quality system implementations. Represent ATQ platform in the development, planning and execution of corporate initiatives and system deployments. Maintain the quality system strategy and roadmap for AT; determine the need for and deploy fit-for-purpose quality systems;
- Drive and coordinate the input for the long-range financial planning (LRFP) process and identify specific needs for the ATQ network (QA and QS) considering future network demand. Ensure strong budgetary management, both CAPEX and OPEX, for ATQ;
- Support manufacturing and lab network extension projects and ensure smooth transfer of knowledge and processes between internal and external nodes to ensure consistent deployment of standards, processes and systems in design and operational phases. Facilitate platform wide understanding and deployment of QA and QS processes and systems;
- Develop and deploy cost competitiveness focus and ensure the culture of continuous improvement is strong within the ATQ network. Support identification, roadmap, sequencing and delivery of Continuous Improvement Projects throughout QA and QS in partnership with the network Site Quality Heads and Lab leads. Implement strong Project Management discipline and focus to execute on Quality projects;
- Partner with ATQ Site Quality Heads and JJRC to identify audit trends impacting the wider ATQ network and support identification of systemic corrective and preventive actions. Advise Quality management of situations that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued. Lead the management and resolution of multi-site quality issues in partnership with Operations, JJRC, DPDS, MSAT and other organizations;
- Enable regulatory outreach. Maintain track of external Quality forums related to Cell & Gene Therapy and ensure adequate Janssen representation. Facilitate review of quality/regulatory guidelines and standards;
- Partner with ATSC Operations leadership and JSCQ Quality Insights team to implement and maintain the Advanced Therapies Quality Management Review (QMR) / Quality Council for the platform; ensure that AT sites provide the necessary data, information and updates for an effective QMR;
- Support the department’s strategic communications initiatives to foster alignment against our objectives, engagement and inspiration including communications campaigns, staff meetings, open sessions, Town Hall meetings; develop content for communications; ensure communications are meeting department needs; measure effectiveness and relevance. Coordinate regular Leadership team and department meetings by developing agendas, recording decisions and action items in each meeting, documenting, and following up on action items between meetings;
- Partner with HR to anticipate and plan for department needs related to our people practices and the HR planning cycle (e.g. calendaring and department-wide communications related to compensation planning, talent management, year-end performance review)

**Qualifications**:

- Experience with Quality Assurance and Quality Systems is required
- Experience with implementing and overseeing GMP operations in a commercial manufacturing facility is required
- Knowledge of cGMP regulations and guidances for FDA/EU is required
- Knowledge of the business environment inside a Quality organization across various roles is required
- Experience in Biologics and/or Cell therapy is preferred
- Strong leadership capabilities, in particular as a change agent, and ability to lead transformations to deliver higher performance
- Strong track record in delivering business improvements projects
- Proven track record working in and supporting a global matrix environment
- Business acumen; previous experience with budget an