Associate Director Plasma & Vaccine Device Quality

Takeda • Lexington, MA

1d

About The Position

The Associate Director Plasma & Vaccine Device Quality (AD PVDQ) provides quality leadership for Takeda’s medical device and combination product life cycle management efforts throughout commercialization until end of life. The role drives collaboration with internal and external partners, on all life cycle management efforts (e.g. post market surveillance, risk management, change requests, etc.). AD PVDQ ensures that Takeda’s medical devices and combination products stay in compliance with global regulatory requirements and international standards (e.g., ISO, AAMI, ANSI). This role actively identifies, leads, and drives implementation of Continuous Improvement (CI) projects in line with department goals, key business outcomes, and strategic plans.

Requirements

• BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred.
• 7+ years of device life cycle management / quality assurance, including a minimum of 4 in device quality, required
• Extensive knowledge of both US and International Device regulatory requirements (specifically 21 CFR Part 820, ISO 13485, ISO 14971), as well as other applicable global regulations as required
• Strong Analytical Skills: Ability to analyze complex processes and identify areas for improvement.
• Project Management: Strong project management capabilities to plan, execute, and monitor CI initiatives.
• Experience in leading design quality activities and influencing senior management required
• Experience with statistical and DMAIC methods required
• Experience with risk management processes and tools required
• Experience with Class I, Class Is, Class II or III medical devices required.
• Experience working with external contract partners for life cycle management, including batch release, supplier notification of changes, supplier alerts, etc. required
• Experience through interacting and collaborating with cross-functional global teams and operational excellence preferred.
• Extensive experience in Device QA for combination products desired

Responsibilities

• Provides industry-leading quality leadership and support for quality life cycle management activities (Deviation, CAPAs, Change Requests, Supplier Notification of Changes, Supplier Alerts, Complaints, event escalations, periodic Risk Management and Post Market Surveillance activities, etc.) of commercialized device and combination products (DCP).
• Accountable for Device Quality functions in oversight of class 1, 2, and 3 drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries) to ensure timely launch and release of Device and Combination Products compliant with all cGMP, SOPs, clinical, device, and regulatory requirements.
• Leadership in implementation of next-generation technologies and design configurations for assigned Device and Combination Products.
• Accountable for living documents management (risk management, Device Master Records, specifications, etc.) of drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries) and to coordinate Clinical Evaluation Reviews and Risk Management updates in the course of post market surveillance activities.
• Represents Device Quality as a risk management Subject Matter Expert in ad hoc Quality Risk Management activities in the course of events.
• Leads activities in preparation for monthly metrics and quality councils and presents data for assigned Device and Combination Products during monthly metrics and quality council meetings.
• Accountable for device Corrective And Preventative Actions (CAPA), deviation and Incident escalation execution of drug delivery devices and combination products or more complex holistic device programs (combination of multiple devices, apps, ancillaries) derived events.
• Responsible for managing post-market activities and customer feedback for complex devices and combination products including complaint investigations, decision trees, complaint trending, and regulatory reporting and maintenance of commercial databases.
• Responsible for quality assessment, for cause activities and for supplier qualification including global shared suppliers for assigned Device and Combination Products.
• Proficient in performing supplier qualification process activities like authoring Quality Agreements and performing supplier audits and can mentor others.
• Leads or hosts Internal and external audits including inspection readiness as a device quality SME.
• In partnership with management, support creation and implementation of the department CI roadmap.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees