Easter Seals Jobs

General Description:

The Associate Director R&D Quality Excellence, Analytics, and Innovation is responsible for supporting and maintaining a proactive, risk-based, and phase appropriate approach to GCP, GVP and GLP Quality Assurance. This role serves to play a critical role in supporting innovation/modernization and driving change including analytics education/development, process modernization and increasing productivity with innovative digital solutions. A key responsibility will be working collaboratively with R&D Quality leadership and cross-functional partners (IT, Clinical Operations, Data Management, RBQM, and Global Quality.) This position will be implementing and overseeing data analytics and digital solutions that contribute to a culture of quality across research and development by providing digitally enabled, data driven, and risk-based tools and processes.

Essential Functions of the Job:

Support and Oversee R&D Quality activities which include, but are not limited to:

• As a member of the R&D Quality Excellence team, contribute to the development of risk-based quality strategy, processes, and tools, and provide expertise and leadership in the areas of data analytics and digital innovation (I.E. Artificial Intelligence, Automation, Data Science.)

• Translate near-term and long-term needs into technical solutions to enhance oversight capabilities using basic and advanced analytics capabilities (e.g. through coding, using visualization software, data science).

• Support identification of opportunities to adopt innovative technologies (analytics, data science, artificial intelligence, etc.) and advanced analytics/digital solutions (data science, NLP, machine learning, LLM)

• Assist in raising awareness and furthering education about data science, data analytics and artificial intelligence capabilities (NLP, machine learning) across Quality.

• Liaison with business owners, RBQM, Data Management, and GTS (IT) on analytics projects to develop business requirements, project timelines, aligned business deliverables and support dashboard modernization.

• Proactively identifying regulatory risks and process gaps through management of data, metrics, Key performance/Quality Indicators (KP(Q)Is) and development of analytics packages to support these efforts.

• Participating in the review of study related metrics (i.e; protocol deviation, etc.) as part of the Quality Management Review (QMR) approach to identify gaps, trends, and the need for process improvements.

• Assisting R&D Quality Inspection Management Teams and cross-functional compliance functions, in developing/adjusting adequate Inspection Readiness (IR) Plans and Strategies, based on review of available data/metrics.

• Assisting R&D Quality audit functions in developing/adjusting the audit scope/strategy, based on review of data/metrics.

• Assisting R&D Quality Internal Audit Team in selection of processes/system for audit and defining scope for selected system/process audits.

• Supporting Quality by Design, Risk Based Quality Management initiatives, and other quality improvement initiatives, in collaboration with cross functional partners and stakeholders.

• Supporting improvement initiatives for key R&D Quality systems, processes and procedures.

• Initiating/assisting/collaborating (in) the development of Quality Improvement (QI) initiatives to ensure data integrity.

• Promoting continuous improvement by partnering with key stakeholders to identify trends in quality events and ensure risk-based solutions are implemented in a timely manner and escalated to senior leadership.

• Participating and representing R&D Quality in meetings and discussions, as required.

• Supporting regulatory intelligence impact assessments on BeiGene processes and procedures.

• Writing, reviewing, and approving Quality - documents (e.g., SOP's).

Additional Qualifications:

• At least 8 years of experience in the pharmaceutical, biotech or technology related industry preferred.

• Experience with Advanced Analytics (Python, R, SQL) and supporting implementation of IT solutions (dashboards, apps,etc.)

• Knowledge in data science and/or data engineering capabilities, including data visualization (PowerBI preferred.)

• Understanding of Data Science market development to be able to come up/explore new ways of delivering analytics solutions to increase their value/contribution.

• Knowledge of LLM Development, application programming interfaces, designing/building Generative AI Algorithms, and passion to learn new innovative technology.

• Knowledge of GCPs, particularly FDA, EMA and ICH requirements preferred.

• Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance preferred.

• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.

• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance.

• Other duties as assigned

Supervisory Responsibilities:

This position will include close collaboration with R&D Quality Leadership Team, R&D Quality staff and other Quality Functions. This role will also collaborate closely with GTS (IT), RBQM, GCO, and cross-functional partners across R&D.

Computer Skills :

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint, Project)

• History of working with Veeva QMS System is preferred

• Knowledge in data science and/or data engineering capabilities.

• Understanding of Data Science/Data Analytics including Advanced Analytics (Python, R, SQL)

• Understanding of data visualization tools (PowerBI preferred.)

• Knowledge of LLM Development/Application Programming Interfaces (APIs) and designing/building Generative AI Algorithms

• Passion to learn new innovative technology.

Other Qualifications:

Education Required:

Bachelor’s degree, preferably in Science or combination of education and 8+ years equivalent work experience. Or MS with 6+ years experience.

Communication & Interpersonal Skills

• Excellent verbal and written communication skills

• Ability to effectively collaborate in a dynamic environment

Significant Contacts

• Quality

• Global Technical Solutions

• Clinical Operations

• Data Management

• Risk Based Quality Management

• Pharmacovigilance

• Clinical Business Operations

• Biometrics

• Medical Monitors

• Regulatory Affairs

• Interacts with all levels of BeiGene

Travel:

May require up to 20% travel

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.