Associate RA Quality, Standards & Training Director

Exelixis•US IL Home Office, IL

5d•$163,000 - $231,000•Onsite

About The Position

The Associate RA Quality, Standards & Training Director provides compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs function, with primary focus on Regulatory Affairs activities. The role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators, metrics and inspection-readiness standards. The Associate Director drives process standardization and consistency by leading compliance monitoring activities, proactively identifying compliance and operational risks, and advancing continuous improvement initiatives. Working cross-functionally with Clinical Operations, Clinical Development and Quality Assurance, the role supports alignment to regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness.

Requirements

Bachelor's degree in related discipline and a minimum of 11 years of related experience; or, Master's degree in related discipline and a minimum of 9 years of related experience; or, Equivalent combination of education and experience.
7 - 10 years of regulatory affairs experience in the pharmaceutical industry.
Ability to develop and manage plans, establish timelines and set standards for performance. Proactively balances commitment and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.
Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-on-one situations and effectively presents information to cross-functional groups of colleagues.
Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
Ability to plan and execute multiple activities.
Ability to consider alternative methods and contingency plans to avoid potential issues.

Nice To Haves

Experience with audits and inspections preferred, but not required.

Responsibilities

Accountable for monitoring SmPC updates for commercially sourced products in Exelixis-sponsored studies.
Ensure accuracy of Reference Safety Information (RSI) trackers to include timely updates of health authority submission dates and approvals.
Track receipt of partner IBs and ensure timely health authority submissions across programs.
Track RFis to completion within the timelines as required per SOP.
Monitor aggregate report compliance to health authorities and CROs.
Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs related documents.
Monitor Regulatory Affairs training compliance via LMS.
Oversee the timely and accurate update of Regulatory Affairs SOPs by working with SOP owners.
Accountable for Regulatory Affairs points of contact for each study kept current with the health authorities.
Assist Regulatory Affairs Strategy Team on development programs as needed.
Monitor and analyze key compliance metrics to assess adherence to applicable procedures, regulations and internal standards.
Contribute to the development of leadership dashboards and slide decks, summarizing compliance performance and trends.
Support the investigation, tracking and timely closure of Quality Events, including root cause analysis and development of corrective and preventative actions (CAPAs), as required.
Collaborate closely with SMEs to support deviation assessment and authorship, ensuring timely and high quality documentation.
Coordinate with GPS and Regulatory Affairs SMEs to conduct impact assessments for new and evolving regulations and support development of implementation plans.
Collaborate with Quality Assurance and cross-functional stakeholders to support health authority inspections across GPS and Regulatory Affairs ensuring the RA function remains in a continuous state of inspection readiness.
Author, review and maintain procedures and standards relevant to Regulatory Affairs.
Partner with Corporate Training to maintain training matrices and ensure training requirements are current and aligned with procedural and regulatory expectations.
Identify and conduct quality-related training to regulatory affairs team members.
Performs other duties as assigned
Complies with all policies and standards