Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Assurance Manager, Device Products in our Lexington, MA. office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
A typical day will include:
The Device Product Lead is an experienced Quality and Technical professional who executes the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda’s commercial products and to bring Takeda’s pipeline products to a sustainable existence on the market.
· Support quality life cycle management of commercialized device and combination products (DCP) to ensure timely release of products in compliance with all regulations, SOPs, clinical, device, and regulatory requirements.
· Execute/approve device CAPAs, deviations, complaint investigations, vigilance assessments, and incident escalations for DCP derived incidents.
· Maintain Design History Files (DHF), Risk Management Files(RMF), Device Master Files (DMR), and Technical Files based on events and post market surveillance reviews.
· Support maintenance and improvement of assigned processes within DCP QMS and support all appropriate activities in preparation for DCP quality management review.
· Ensure robust Supplier Quality Management program for DCP suppliers, including auditing of suppliers, quality agreements, documentation and governance and management of the quality interface with responsibility for the ultimate release of DCP.
· Providing sustainable Device QA support for internal and external manufacturing, packaging, testing and release of DCPs. Perform batch release for DCP.
· Drive launch readiness activities and support regulatory filings.
· Life cycle management of assigned Takeda DCP products in compliance with applicable regulations.
· Subject matter expert for assigned DCPs and product related QMS processes
· Ensures robust manufacturing, testing, and product review.
· Participate on teams sustaining and/or improving DCP and developing global policies and procedures for DCPs
· Monitors and analyzes DCP quality performance to demonstrate levels of control, capability, and compliance
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
· 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.
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
· Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
· Strong decision-making skills even in times of uncertainty. Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
· Collaborative team player with good communication skills
· Ability to influence others to deliver business results and lead a global team
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
· Accountable for analyzing product information, driving improvements in process as a result of product knowledge.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
· Deals with ambiguity while making quality decisions, assessing performance and driving change
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
· Bachelor’s Degree in BS in Engineering or equivalent technical discipline required and at least 8 years of experience working with medical devices and/or combination products in a regulated healthcare industry within Quality Assurance, Quality Engineering, and/or Quality Compliance roles;
· Expert knowledge of international regulations for Device and Combination Products with full understanding of European, International, and US requirements for Design Control, Supplier Management and Risk Management guidelines, Post Market Surveillance, CAPA, etc. primarily emphasis on ISO 13485:2016, MDSAP, ISO 14971, and 21 CFR Part 4, 820, 803.
· Experience with Class I & II & III sterile and non-sterile medical devices
· Experience with clinical development and regulatory filings
· Experience working with external manufacturing partners; assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; understanding of GDPs and global supply and distribution networks.
· Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred
Desired: Advanced Degree; Experience working Pharma/Biotech/Device Quality functions preferred, Green Belt or Black Belt certification; Auditor certification. Experience with intravenous and subcutaneous administration devices.
This job posting excludes Colorado applicants.
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