Associate Director, Quality Systems Management Team Lead (Hybrid)

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Job Description

Job Title: Team Lead, Global Systems and Compliance, Vaccine Business Unit

This is an Associate Director level position with 4 direct reports, but at Takeda we title our AD roles as "Lead"

Hybrid Role - Required to be within commuting distance of the office and be in the office 2 days per week

Location : Cambridge, MA or CHE, Zurich HQ

About the role:

The Quality Systems & Compliance Team Lead manages the Takeda Vaccines BU Quality Systems & Compliance team and ensures that a risk-based QMS is established for early and late stage development & commercial product manufacturing and testing. The Quality Systems & Compliance Team Lead ensures that the QMS is compliant with all applicable regulatory requirements and with internal standards and guides continuous improvement of the QMS.

• You will represent VBU Quality in global teams and ensure close collaboration and with all partner groups falling under the QMS. Provide important guidance and facilitate daily operations of VBU Quality Management Systems (QMS) following and regional projects.
• Lead the management and administration of VBU GxP LMS training assessments and assignments to applicable personnel. Produce reports, monitor training compliance and perform tracking and trending of relevant training data. Evaluate gaps and develop corrective actions to close gap

How you will contribute:

• Participate as a vaccine leader to support Takeda global projects and procedures for QMS and associated electronic systems
• Lead team members, including Performance Reviews, Setting of Goals, Development plans, and Leading staff meetings.
• Operational oversight of group including the planning of work (Project Management) and coordination of activities of the team
• Support department reviews, including quality councils and implementation of Global Standards and Processes
• Lead the Development of Continuous Improvement Projects within the Department and across VBU.
• Other Responsibilities and Projects as assigned.

Quality Management System (QMS)

• Operate global vaccine QMS in compliance with regulatory and Takeda standards
• Ensure continuous improvement planning to ensure improving compliance, effectiveness, and efficiencies
• Provide guidance to the global vaccine community to set an aligned QMS execution and act as primary contact and support for training and documentation related questions and issues
• Responsible for quality oversight of VBU GxP document lifecycle states in the DMS
• Responsible for management of VBU GxP training assessments and assignments to applicable personnel
• Operational Oversight for coordinating quality events/processes (deviation, change control) and support review board activities as applicable
• Manage quality metric reporting and periodic assessment of the health of VBU quality systems
• Manage process and technology projects for VBU and Takeda quality systems; participate in continuous improvement projects
• Author, approve and maintain procedures supporting quality systems maintaining compliance with regulations and Takeda policies

Compliance

• Lead the implementation of inspection readiness activities
• Lead the establishment of Goals for performance and compliance monitoring, continuous improvements
• Implement inspection readiness and remediation's
• Oversee the compliance governance processes for the change control review board and specification committee, risk register, and quality event notifications

Technical/Functional (Line) Expertise

• Expertise in laboratory and stability investigations
• Expert in quality systems management
• Experienced in working with global teams
• Experienced with quality and manufacturing operations
• Experienced in providing audit support (either remote or on-site)
• Fluent in English (written and oral)

Leadership

• Lead projects and improvement projects
• Team Player
• Seek and used Quality Conversation as an opportunity for improvement.

Decision-making and Autonomy

• Support the Global and Local team.
• Knowledge of budget creation and financial management
• Achieve continuous improvement and analysis

Interaction

• Frequent contacts with equivalent level managers and customer representatives concerning projects, operational decisions, scheduling requirements, or contractual clarifications.
• Conduct briefings and technical meetings for internal and external representatives.
• Work both in collaborative teams and the capability to influence/negotiate/compromise within teams to move projects forward.
• Interaction with different Health Authorities in the course of inspections

Innovation

• Technical expertise, experience, to identify opportunities for improvement and share new perspectives and best practices throughout the network with all sites.
• Identify and organize creative ways of communication to best-possible share knowledge throughout the network.
• Conduct work in compliance with cGMPs and regulatory requirements

Complexity

• Work on complex problems in which analysis of situations or data requires an in-depth evaluation of multiple factors.
• Exercise judgment within defined practices in selecting methods, techniques, and evaluation criteria for obtaining results.
• Ensure budgets, schedules, and performance requirements achievement. Expected to escalate issues in a timely fashion.
• Cultural considerations and knowledge of site-specific needs are necessary for the successful implementation and maintenance of the different projects and global procedures

What you bring to Takeda:

Education / experience

• 10+ years of experience in a GMP-Environment in the Pharmaceutical Industry is required
• 5+ years of leadership experience
• BS degree in Science or Engineering (advanced degree preferred) and several years of experience in the pharmaceutical Industry
• Minimal travel, but there could be some domestic or international

Required skills / Skills

• Experience with Investigational and Commercial troubleshooting
• Experience in different Quality functions
• Experience in managing global communities

Leadership Behaviors

• Global Cultural Awareness
• Conduct work in compliance with cGMPs, safety and regulatory requirements
• Seek and consider feedback.
• Experience working with projects
• Limited travel expected. Travel to Global and Local sites may be required.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional development opportunities
• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran . click apply for full job details