Quality Manager, Pharmaceutical Sciences & Device Quality Operations
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.
Life at Takeda
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2021.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Quality Manager, Pharmaceutical Sciences & Device Quality OperationsApply Now
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 a Quality Manager Pharmaceutical Sciences & Device Quality Operations in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Manager working on the R&D Quality team, you will be empowered to coordinate the execution of the overall implementation and management of GMP supplier quality strategy and processes for the Pharmaceutical Sciences & Device Quality organization. A typical day will include:
Collaborate effectively with internal Takeda stakeholders (e.g., Pharmaceutical Sciences, Clinical Supply Chain, Procurement, Global Quality Auditing & Supplier Management) to manage the qualification of GMP suppliers.
Support the supplier identification and site selection process, Quality due diligence activities, establish supplier risk assessments and facilitate new supplier qualification requests.
Manage the R&D GMP Quality Management Lifecycle processes for qualification and maintenance of suppliers to ensure compliance. Processes include but not limited to Quality audits, Quality Agreements, notifications of change and supplier quality performance metrics.
Support development and execution of supply chain compliance and control strategies.
Manage the non-medical product complaint process to ensure product complaints pertaining to clinical trial material are received, investigated, closed, and tracked/trended in compliance with cGMP and Takeda requirements
Support the compliance and execution of the Stock Recovery Process utilized for the removal, recovery, or correction of Takeda’s clinical trial materials when and if determined necessary
Lead and implement critical projects which enhance Pharmaceutical Sciences & Device Quality’s efficiencies and innovation
Additional duties as assigned
Technical/Functional (Line) Expertise
Working knowledge of current Good Manufacturing Practice requirements for the biopharmaceutical and medical device industries
Experience in supplier quality management and auditing GMP suppliers (e.g., CMOs)
Experience with risk management strategies and general project management
Proven success in identifying and implementing continuous improvement initiatives
Proficient in analyzing data to identify performance trends
Ability to proactively manage the development and re-engineering of key processes and systems in support of the business’s mission
Demonstrated teamwork, initiative, and problem-solving skills
Clear, concise and consistent in written and verbal communications
High attention to detail
Decision-making and Autonomy
Independently manages projects, carries out root-cause investigations, analyzes data and makes recommendations to management
Experience working within complex/matrixed organizations
Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization
Ability to read, analyze and interpret common scientific and technical data/reports and legal/regulatory documents
Effectively presents information to management, internal groups and stakeholders
Analytical capabilities with the ability to analyze a wide variety of information and data to determine potential risks
Ability to anticipate potential problems and risks related to quality expectations and regulatory compliance, formulate action plans, and implement solutions
Ability to work effectively in a fast paced, rapidly changing environment and to work on multiple work streams and projects simultaneously
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Bachelor’s Degree in Chemistry, Biology, Engineering or related field
Minimum of 6 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GMP Quality or Compliance
Six sigma/lean processing, project management professional and/or auditor certification preferred
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
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
Empowering Our People to Shine
Learn more at takedajobs.com
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Time TypeFull time
Job ID R0029658