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Associate Director, Quality Assurance Lead
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Associate Director, Quality Assurance Lead
Job ID RDate posted 07/16/2020 Location Hoofddorp, Netherlands
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Quality Assurance Lead in The Netherlands (Amsterdam).
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a function of the External Supply Plasma Quality (EPQ) Team, this role is ensuring Quality Oversight related to plasma operations, in particular for the compliance and quality of intermediates, drug substance (DS) and drug product (DP) manufactured by external Contract Manufacturing Organizations (CMOs) globally within the Plasma Operating Unit (OpU). A typical day will include:
• Managing a team of 3-4 persons located at a CMO in Amsterdam
• Assign, train, develop and lead QA and QP resources overseeing the CMOs
• Partnering with CMO to ensure all relevant operational activities, product disposition and quality tasks are performed as defined by relevant procedures and Quality Agreements, and ensure compliance of CMO with GMP regulations and license registration of Takeda Plasma Derived Products
• Timely and compliant disposition of intermediates, DS and DP produced by CMOs
• Maintaining inspection ready CMO facilities and operations in line with Takeda standards and global regulatory expectations and requirements.
• Leading the Amsterdam based Quality Team overseeing the CMO's
• Disposition of intermediates, DS and DP produced by CMOs
• Identifying risks and implementing changes to ensure compliance to Takeda’s standards and applicable regulations
• Maintaining inspection ready facilities and operations in line with Takeda standards and global regulatory expectations and requirements
• Act as Takeda Quality representative for Takeda Plasma Derived Products manufactured at CMO’s entity
• Support Person In Plant activities including presence at the CMO
• Implement adequate communication processes and maintains CMO partnership
• Maintain required Quality systems databases
• Support business/Quality review meetings with CMO/external parties and representing Takeda in a professional manner
• Manage Deviations with CMOs and/or with Takeda (as Deviation Owner or Quality Approver) for Takeda products
• Manage change control records (as Change Owner or Quality Approver) for Takeda products
• Review and provide status reports of compliance related records such as Deviation reports, CAPAs, Change requests, Technical Quality Agreements, Complaints, as instructed
• Manage CMO Quality Agreement redaction, review and updates
• Support the preparation of Quality Metrics/ KPIs for EPQ
• Support the generation and the review of APQR’s for Takeda Products in close cooperation with respective CMO’s or plants.
• Support projects as Quality representative of CMO and EPQ team including support of regulatory activities for the review of variations or license registration
• Support investigation and management of complaints for Takeda products
• Support Global Drug Safety for the investigation of adverse events (AE) trend when applicable
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Education / experience
• Requirement of a Master degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.)
• Minimum of 10 years of proven experience in a QA related position in the pharmaceutical industry
• Demonstrated experience working with / preparing Standard Operating Procedures and working with / improving Pharmaceutical Quality Management systems.
• Knowledge and understanding of cGMP (EU / US as applicable) regulations.
• Fluent (written and spoken) Dutch and English
Core Competencies / Skills
• Strong knowledge of cGMP, global regulatory guidelines, and validation practices. Experience with Aseptic processing , GMP and Plasma Derived Products regulations
• Experience with pharmaceutical quality and compliance management systems
• Ability to effectively lead in a matrixed environment
• Leading and implementing root cause analysis and effective investigation practices
• Practical knowledge of working with QMS databases like TrackWise and Microsoft Office tools.
• Continuous improvement to drive efficiencies and improve turnaround times
• Demonstrate the Takeda Leadership Behaviors: strategic enterprise thinking; Inspires and enables people; Focus on few priorities and deliver superior results; elevate the capabilities of the organization..
• Proven people manager and effective leader capable of developing people and teams, driving a high-performance organizational culture
• Fostering an environment that embraces employee development and holds teams responsible for managing performance, developing a strong talent bench, and succession plan for key roles.
• Good interpersonal skills, ability to influence and effectively communicate to all levels internally and externally
• Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills (English and Dutch are required).
• Strong process improvement mindset: proactively addressing quality and compliance issues, ability and experience to develop gap analysis and action plans, critical thinking / evaluation of process problems.
Check out where you could be
working if you apply.
Job Seekers: Protect yourself against identity theft
Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
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