·         Support projects and initiatives within the Oncology and External Supply Small Molecule (ESSM) Quality – US Region organization to ensure Quality Compliance with GxP regulations and quality/technical agreements.

·         Support the successful execution of regulatory body visits, both internally and at Contract Manufacturing Organizations (CMOs), by supporting the pre-inspection activities, overseeing the fulfilment of requests during the inspection, and coordinating post-inspections activities as assigned.

·         Performs or supports the execution of the following activities:

·         Ensure consistent application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US.

·         Tracking of required corrective actions resulting from self-assessments or inspection readiness activities.

·         Participate as an integral member of the Inspection Readiness team and support during all internal, vendor and Alliance/Corporate Partner compliance or regulatory audits/inspections of Oncology and (ESSM) – US Region departments.

·         Perform weekly monitoring of quality systems for any adverse compliance trends and escalate any risks to management.

·         Support the Oncology and ESSM US Region Document Management and Training process owner in th the development and implementation of training curriculums, and develop training material for local procedures.

·         Support the collection of pertinent compliance-related information for Annual Product Reviews (APR) and/or Periodic Product Reviews (PQR).

·         Support the Supplier Qualification Program with up-to-date information to ensure the accuracy of data used for audit planning, GMP certificate renewals and generation of the Approved Supplier List.

·         Receive overall project direction from management but completes most work independently.

·         Independently write new Oncology and ESSM Quality procedures and revise existing procedures.

·         Complete required training and keep training files current.

·         Additional tasks and duties as assigned.

·         Bachelor of Science (BS) degree and 3+ years’ experience in QA or related compliance area in the pharmaceutical/biotech industry.

·         Knowledge of cGMP regulations for US, EU and other markets including audit knowledge and skills.

·         Effective time management, detail-oriented work style, and superior at teamwork and collaboration.

·         Excellent organizational, presentation development and delivery skills.

·         Proficient computer, verbal and written communication skills.

·         Ability to handle multiple tasks concurrently and in a timely fashion.

·         Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.

·         Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.

·         Must be able to read, write and converse in English.

·         Must display eagerness to learn and continuously improve.

·         Positive work attitude that supports teamwork and continuous improvement.

·         Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

·         Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint, Learning/Document Management Systems and Trackwise.

·         Wrist and hand motion (e.g. typing, writing).

All your information will be kept confidential according to EEO guidelines.