Project Manager, GMP Quality Assurance (Biologics)
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.
This experienced Quality Manager will be primarily responsible for providing Quality support of the biologics programs at Takeda, as well as small molecule programs, as necessary. This person will also play a lead role in helping transition QA/product release efforts for two high profile products from a Takeda site in Denmark which is being closed for strategic reasons. Select activites include: ensuring that all drug substance, drug product, and finished goods intended for use in clinical trials are manufactured and tested in accordance with FDA, ICH and global GMP requirements as well as Takeda Corporate Quality standards. Additionally, this position will support other key quality initiatives such as the Process Validation program.
DUTIES & RESPONSIBILITIES:
•Responsible for managing programs of moderate complexity and risk.
• Responsible for providing vendor oversight through regular communication and as required, CMO site visits.
• Responsible for making most Quality decisions on multiple projects o Review and approve batch records and other applicable product-related technical documents. o Review and approve deviations, investigations, CAPA's, OOS investigations, SOP's and other applicable quality documents, as applicable. o Disposition investigational materials intended for use in clinical trials.
• Escalate Quality decisions that have an impact on project timelines and/or budget or any added risk
• As required, will provide on-site presence at CMO during critical manufacturing operations
• Will identify and support opportunities and initiatives to drive consistency and efficiency within Quality activities
• May perform vendor and internal audits, as necessary
• May manage/lead teams or initiatives
• Responsible for staying current on GMP requirements
• Support periodic quality reporting by providing timely information re: of vendor/project issues/performance
• Proven experience in leading Biologics Quality support, small molecules experience a plus
• Excellent interpersonal, communication and writing skills.
• Strong working knowledge of FDA, EMA and ICH GMP requirements
• Ability to work independently while collaborating regularly and effectively in a team environment.
• Ability to build and maintain positive relationships with all stakeholders, department peers, vendors and CMC team representatives.
• Process Validation and Quality by Design (QbD) experience highly desirable
• Experience in corporate integration activities, a plus Minimum Education and Experience:
• BS or equivalent and 8+ years of relevant experience or
• MS and 6+ years of relevant experience
To apply for this position, please CLICK HERE