The Associate Director, Global Development Quality Standards & Continuous Improvement will support leadership with the effective oversight and maintenance of the Global Development Clinical Quality Management System (QMS), quality event oversight and improving processes for quality standards, governance, and oversight, as assigned. The Associate Director, may also be assigned to line manage, coach and/or mentor more junior members of the team and/or serve as a sub-function area lead, process owner or business process owner.
Key responsibilities may include:
Acting as a SME in the area of quality management system oversight, governance of quality processes, quality event oversight and continuous improvement
Supporting the creation and implementation of best practice quality strategy, policies, processes, and procedures, to champion a culture of continuous improvement within Global Development
Responsible for leading the engagement with key customers across Global Development functions to proactively identify process improvements, standardizations and regulatory compliance that impacts the Regeneron Global Development quality system
Being responsible for the reporting and provision of quality-related metrics and trends to enable functions to continuous improvement.
Coordinating areas of the Quality Event (QE) portfolio and the provision of SME expertise and guidance to relevant functional areas
Supervising and ensuring the support of the functional team for the review and analysis of quality data, including effective root cause analysis and Corrective Action/Preventive Action (CAPA) development; and ensuring and responsible for collaboration with internal leaders and functional stakeholders to define meaningful Quality System Metrics (KQIs/KPIs) to measure the health of the QMS, including establishing criteria, thresholds, reporting, key takeaway messages, resulting actions and measures of efficiency
Overseeing and ensuring participation in governance and oversight activities, including
Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP).
Experience in training, supervising, line management, mentoring and development of staff, and leading a small team.
Advanced knowledge, understanding and application of GCP, guidelines including the management of significant/complex quality issues and compliance activities.
Extensive experience in providing training and presenting information on key quality and regulatory compliance information.
Advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.
Experience with participating in, managing and leading Regulatory Agency Inspections, in addition to serving as a Subject Matter Expert.
Ability to interpret, understand and execute processes, including the identification of process gaps and improvement opportunities.
Advanced understanding and application of project management skills including planning, organization, prioritization, and time management.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.