Lead Device Product Quality Management (Hybrid)

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Job Title: Lead Device Product Quality Management

Location: Lexington, MA, USA - Vienna, Austria

About the role:

• The Lead Device Product Quality Management provides quality leadership for Takeda’s medical device and combination product life cycle management efforts throughout commercialization until end of life.
• Drives collaboration with internal and external partners, on all life cycle management efforts (e.g. post market surveillance, risk management, change requests, etc.).
• Ensures that Takeda’s medical devices and combination products stay in compliance with global regulatory requirements and international standards (e.g., ISO, AAMI, ANSI).

How you will contribute:

• 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.
• Manages quality improvement initiatives and design improvements in addition to driving process improvements that impact Takeda.
• Leads activities in preparation for monthly metrics and quality councils and presents data for assigned device and combination products during monthly metrics and quality councils’ 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.

What you bring to Takeda:

• Lead Device Product Quality Management is the lead in all quality aspects of device and combination product life cycle management activities from commercialization until end of life.
• Role is accountable for conformity of all life cycle management deliverables with applicable regulatory requirements.
• Role is expert in complex problem solving, applying tools to the team to assess and resolve issues in the course of life cycle management efforts while escalating as required.

Technical/Functional (Line) Expertise

• Strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to use that information to make scientifically sound quality risk-based recommendations and decisions.
• Works closely with Commercial Device Engineering, Regulatory, Medical Affairs, External Manufacturing, Supply Chain and with external manufacturing partners.

Leadership

• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team member, share information, and deliver results with a team.

Decision-making and Autonomy

• Excellent analytical and problem-solving skills.
• Strong decision-making skills.

Interaction

• Ability to influence others to deliver business results.
• Strong time management skills and the ability to prioritize activities.

Innovation

• Accountable for analyzing product information, driving improvements in process as a result of product knowledge

Complexity

• Coordinate activities with SMEs across multiple time zones.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Escalation of potential device issues to direct management 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.
• 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, and experience with implantable devices preferred.
• 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.

• Desired: Extensive experience in Device QA for combination products and implantable devices.

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 training and 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. In this role, 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/or 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, as necessary.
• 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 best in class patient support programs. Takeda is a patient-focused company that will 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.

#GMSGQ #ZR1 #LI-MA1

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, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.