Senior Manager, GMP Quality Assurance - Small Molecule
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.
* The Senior Manager, GMP Quality Assurance is responsible for developing and ensuring site execution of quality strategies that ensure Clinical Trial Material (CTM) utilized in Takeda clinical studies are produced in compliance with applicable regulations and Takeda quality expectations, and are released in a timely manner to meet clinical study and developmental timelines.
* This position is directly responsible for a team of QA subject matter experts and manages the development, implementation, and maintenance of GMP quality operations which support pharmaceutical development and the CTM supply chain (manufacturing, packaging, testing, and distribution) for Takeda's Americas region.
* The Senior Manager, GMP Quality Assurance develops strategic direction and ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity
* Develop and lead the site quality operations strategy specific to a globally-outsourced CTM supply chain that ensures Takeda quality expectations, minimizes compliance risk, and assures current Good Manufacturing Practice (cGMP) compliance. Lead internal staff and outsourced personnel/vendors in execution of strategy and identify continuous improvement plans and opportunities.
* Manage a team of direct reports responsible for daily GMP quality operations and timely disposition of CTM to support Takeda developmental timelines, while assuring product quality and compliance. Develop solutions to complex issues and Quality initiatives with local and impact, following cGMP regulations and Takeda standards
* Organize and develop timely action plans in close coordination with area leadership, ensuring a seamless execution of successful QA strategies for the site. Advance GMP QA's ability to provide support to internal stakeholder strat
egies based on a thorough understanding of and alignment with key business drivers and company strategy.
* Have strong knowledge and understanding of the global CTM supply chain. Identify, understand, analyze, and identify risks and quality issues, and develop mitigation strategies.
* Provide site leadership to ensure timely, well-documented, and compliant resolution of quality issues and implementation of corrective actions that maintain a continual state of regulatory compliance for pharmaceutical development activities and CTM-related operations.
* Collaborate effectively with Global IMP Quality (GIQ) colleagues in other regions and sites to develop improvements and align support for global operations related to Takeda investigational compound development.
* Develop and implement inspectional readiness strategies, assess potential risks, and determine necessary actions to mitigate risks in advance of GMP regulatory inspections related to Takeda
new drug submissions. Provide management support for regulatory inspections of third-party vendors or Takeda locations.
* Lead qualification audits of new and current vendors associated with Takeda's investigational drug supply chain. Make recommendations to Takeda management concerning the use of vendors based on audit findings.
* Manage a process to transfer compound-specific quality knowledge gained during the drug development process to the appropriate Takeda commercial-product QA organization(s).
* Maintain awareness of emerging issues and regulatory trends, provide interpretation, and communicate effective impact assessments and mitigation plans to QA management.
* Bachelor's Degree in Chemistry, Biology, Engineering or related field. Experience:
* Minimum of 10 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 7 years in GMP QA/QC/Compliance. * At least 3 years of managerial experience.
* Experience in Quality Assurance of drug product through the lifecycle of pharmaceutical product development.
* Track record of successfully working with and managing third-party vendors.
* Experience applying GMP Quality knowledge through standard operating procedures (SOPs) to facilitate business operations and in some cases, develop procedural solutions to appropriately resolve quality and compliance challenges.
* Experience working in a virtual organization and applying Quality Systems in such an environment (e.g., change control, deviations, CAPA, complaint management, and documentation management among others).
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