Senior Manager, GLP Quality Assurance
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
Reporting to GLP leadership in Japan, this position is located in Cambridge and will be responsible for GLP quality assurance in the US including establishment of appropriate QA procedures, providing support and training to GLP employees, providing coordination and support for internal and external audits including regulatory inspections, planning, performing and reporting audit for studies and facilities including CROs. And also to assure the accuracy of CTDs (module 4) that include GLP and non-GLP studies. RESPONSIBILITIES
Establishes and revises Policies / SOPs / manuals on quality assurance to adapt to changes in business environment and laws, regulations and their interpretations in alignment with QA policy.
Participates in creating DMPK and DSRE SOPs and policies that adhere to regulatory guidance.
Plans and conducts appropriate GLP audits creates audit reports and QA compliance statements in accordance with the law and regulations. This inclu
des nonclinical study audits, facility audits, process audits and CRO audits outsourced by TBOS, TCAL and SRC and licensors.
Maintains organizational awareness of regulatory developments and requirements; and responsible for ensuring all potential GxP compliance issues are identified and brought to the attention of appropriate business managers in a timely manner. Audits to ensure that the contents of CTDs accurately reflect the study data and the related documents (GLP and non-GLP DMPK studies).
Maintains the Master Schedule Sheets.
Prepares audit reports in the appropriate audit management systems.
Cooperates and collaborates with the PRD QA colleagues across TAKEDA sites to conduct joint audits, resolve QA issues and to harmonize and improve QA operations. This includes involvements of activities in R&D QA and Global QA.
Provides consultation and education to maintain GLP compliance to relevant researchers and operational staff.
Keeps up-to-date with the current GLP regulatory requirements and regulatory authorities' interpretation on GLP, and shares the information with relevant persons and provides guidance on how to meet the requirements. QUALIFICATIONS
Minimum 3+ years GLP QA experience.
Bachelor degree. Takeda provides equal employment [and affirmative action] opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups.
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