Job added in hotlist
Applied job
Contract job
90-day-old-job
part-time-job
Recruiter job
Employer job
Expanded search
Apply online not available
View more jobs in Lexington, MA
View more jobs in Massachusetts

Job Details

External Supply Quality Manager

Location
Lexington, MA, United States

Posted on
Oct 17, 2021

Apply for this job






Profile

Job Description
Job Title: External Supply Quality, Manager
Location: Lexington, MA
About the role:
You will have responsibility for Quality Assurance, and support of Quality Control, for external Oncology and Small Molecule manufacturing (contract manufacturing organizations, or CMO) and external testing (contract test labs, or CTL), inclusive of API, DP, packaging and labeling activities, located within the US/North American region.
You will support the strategy and plans for the ESQL Quality organization to meet the Quality and Operating Unit vision and objectives, assist in establishing priorities and building a regional patient-centered best in class organization, execute on Quality Improvement projects.
How you will contribute:
Accountable for the product quality performance at designated CMOs, to ensure compliance and quality risks are identified, communicated and mitigated, and are an integral part of business decisions consistent with cGMP and Takeda Global Quality Standards.
Responsible for product quality performance through product and supplier Quality Risk Management, deviation/investigation review, change management, APQR evaluation, supplier auditing, Key performance Indicators (KPI) and other Quality processes and tools as required. Maintain product and process. Supports an environment of continuous improvement.
Supports and champions implementation of compliance strategies, quality plans and Commercial Quality Assurance programs for the management of Takeda outsourced material procurement, product manufacturing/packaging operations to assure the quality and compliance of Takeda and partner products.
Represent Takeda to make decisions on acceptability of quality programs and ongoing activities at the CMO.
Establish quality and compliance expectations for CMOs and CTLs; performing strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP's and Takeda Quality System expectations.
Provide oversight in the assessment of changes or deviations for Takeda products, to assure compliance to regulatory commitments, assessment and evaluation of risks, appropriate disposition of product, and correction or improvement of operations to minimize future risks.
What you bring to Takeda:
Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline
8 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
Experience with cGMPs, ICH and other relevant regulations
Project Management expertise desired.
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
Flexible Work Paths
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.
#GMSQ
This job posting excludes CO applicants.
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.
Empowering our people to shine:
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.
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.
Locations
Lexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Apply
Save Job
Share This Job
LinkedIn
Facebook
Email
Xing
Explore The Area
Related Jobs
View All of Our Available Opportunities
Recently Viewed jobs
No jobs have been viewed recently.
Saved jobs
Sorry, you do not have any saved jobs.
Related Content
BioLife Plasma Services
Explore More
Biotech Site in Covington, GA
Explore More
Global Top Employer 2021
Explore More
Sign up for Job Alerts
Sign up to receive the latest career opportunities directly to your inbox.
First Name
Last Name
Phone Number
Email Address
Interested In
Select a job category from the list of options. Select a location from the list of options. Finally, click “Add” to create your job alert.
Category
Select a Job Category
Automation and AI
Business Administration
Business Development
Clinical Development
Communications and Public Affairs
Contingent Workers
Customer Service
Data Sciences
Drug Safety
Engineering
Environmental Health & Safety
Ethics and Compliance
Finance
Human Resources
Information Technology
Insights & Analytics
Intern/trainee/apprentice
Legal
Manufacturing Sciences
Manufacturing/Production
Medical Affairs
Other
Patient and Market Access
Pharmaceutical Sciences
Plasma Management
Process Improvement
Procurement
Project/Program Management
Quality
Real Estate, Facilities, and Security
Regulatory Affairs
Research Science
Sales and Marketing
Strategic Planning
Supply Chain
Therapeutic Area Unit
Training
Location
Select Location
Aktyubinskaya Oblast’, Kazakhstan
Alabama, United States
Almaty, Kazakhstan
Arizona, United States
Bács-Kiskun, Hungary
Baden-Württemberg, Germany
Bangkok, Thailand
Baranya, Hungary
Beijing Municipality, China
Bogota D.C., Colombia
Borsod-Abaúj-Zemplén, Hungary
Brandenburg, Germany
Bratislava, Slovakia
Brussels Capital, Belgium
Budapest, Hungary
Buenos Aires F.D., Argentina
Cairo Governorate, Egypt
California, United States
Campeche, Mexico
Canton of Neuchâtel, Switzerland
Canton of Zurich, Switzerland
Capital Region, Denmark
Carinthia, Austria
Central and Western District, Hong Kong SAR
Central District, Israel
Central Java, Indonesia
Csongrád megye, Hungary
Dagestan, Russia
District of Columbia, United States
East Java, Indonesia
East Kalimantan, Indonesia
England, United Kingdom
Estado de Bahia, Brazil
Fukuoka, Japan
Georgia, United States
Hajdú-Bihar, Hungary
Hawaii, United States
Henan, China
Heves megye, Hungary
Hiroshima, Japan
Hokkaido, Japan
Île-de-France Region, France
Illinois, United States
Indiana, United States
Iowa, United States
Istanbul, Turkey
Jakarta Special Capital Region, Indonesia
Jiangsu, China
Kanagawa, Japan
Kansas, United States
Kentucky, United States
Khabarovsk, Russia
Kumamoto, Japan
Kyiv City, Ukraine
Kyoto, Japan
Land Berlin, Germany
Latium, Italy
Leinster, Ireland
Łódź Voivodeship, Poland
Louisiana, United States
Lower Austria, Austria
Madrid, Spain
Maharashtra, India
Maryland, United States
Massachusetts, United States
Mazovia, Poland
Mecca Region, Saudi Arabia
Metro Manila, Philippines
Mexico City, Mexico
Michigan, United States
Minnesota, United States
Mississippi, United States
Missouri, United States
Moscow, Russia
National Capital Territory of Delhi, India
Nevada, United States
New Jersey, United States
New South Wales, Australia
New York, United States
North Holland, Netherlands
North Sumatra, Indonesia
Novosibirsk Oblast, Russia
Nur-Sultan, Kazakhstan
Ohio, United States
Oklahoma, United States
Ontario, Canada
Oregon, United States
Ōsaka, Japan
Paraná, Brazil
Penang, Malaysia
Pennsylvania, United States
Pernambuco, Brazil
Riau, Indonesia
Rio de Janeiro, Brazil
Riyadh Region, Saudi Arabia
Salzburg, Austria
San Juan, Puerto Rico
São Paulo, Brazil
Seoul, South Korea
Shanghai Municipality, China
Smolensk Oblast, Russia
South Sulawesi, Indonesia
South Sumatra, Indonesia
St.-Petersburg, Russia
Stockholm County, Sweden
Styria, Austria
Szabolcs-Szatmár-Bereg, Hungary
Taiwan, Taiwan
Tennessee, United States
Texas, United States
Tianjin Municipality, China
Tokyo, Japan
Tuscany, Italy
Tyrol, Austria
Upper Austria, Austria
Uusimaa, Finland
Veneto, Italy
Vienna, Austria
Viken, Norway
Virginia, United States
Volgograd Oblast, Russia
Wallonia, Belgium
Washington, United States
West Java, Indonesia
Wisconsin, United States
Yamaguchi, Japan
Yaroslavskaya Oblast’, Russia
Add
Quality, Lexington, Massachusetts, United States
Remove
Remove
Upload Resume
Remove
Confirm Email
By submitting your information, you acknowledge that you have read our privacy policy
and consent to receive email communication from Takeda Pharmaceuticals.
SUBMIT
Terms of Use
Privacy Policy
EEO Statement
Accommodations
Sitemap
Job Seekers: Protect yourself against identity theft
Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers.
At Takeda, we do not ask for personal financial information during telephone, in-person or video interviews. And we are investigating ways to mitigate or stop this scheme. If you have concerns related to this issue, consider the following actions: 1) If in the U.S., place a freeze on your credit reports: ****2) file a complaint with the U.S. Federal Trade Commission: ****and/or 3) file a report with your local police department.
Copyright 1995-2021 **MEMBERS ONLY**SIGN UP NOW***. All rights reserved.
Connect with us:
Visit us at LinkedIn
Visit us at Twitter
Visit us at Glassdoor
Visit us at YouTube
Worldwide

Company info

Sign Up Now - ChemistryCrossing.com

Similar Jobs:
Job Description Testimonials Who We Are Culture Job Type: Full Time Job Level: Senior Travel: Minimal, if any At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people ...
Research Scientist
Location : Boston, MA
Job Description Testimonials Who We Are Culture Job Type: Full Time Job Level: Senior Travel: Minimal, if any At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people ...
Project Engineer
Location : Newton, MA
Position Summary This position provides technical services supporting the execution of projects for Desalitechs clients in North America. In this position, the Project Engineer i) supports the coordination of the work between th...
The number of jobs listed on EmploymentCrossing is great. I appreciate the efforts that are taken to ensure the accuracy and validity of all jobs.
Richard S - Baltimore, MD
  • All we do is research jobs.
  • Our team of researchers, programmers, and analysts find you jobs from over 1,000 career pages and other sources
  • Our members get more interviews and jobs than people who use "public job boards"
Shoot for the moon. Even if you miss it, you will land among the stars.
ChemistryCrossing - #1 Job Aggregation and Private Job-Opening Research Service — The Most Quality Jobs Anywhere
ChemistryCrossing is the first job consolidation service in the employment industry to seek to include every job that exists in the world.
Copyright © 2021 ChemistryCrossing - All rights reserved. 169 192