Quality Manager, Quality CMO oversight
Quality Manager, Quality CMO oversightJob ID R0097018 Date posted May. 23, 2023 Location Dublin, Ireland
Job Title: Quality Manager, Quality CMO oversight
Location: Baggot Street
About the role:
The Quality CMO oversight team is accountable for oversight of Biologics product manufactured at CMOs on behalf of Takeda.
The scope includes Drug Substance, Drug product and Finished Drug Product CMOs
This team will work with our external CMO partners and internal Quality teams within this department .In addition this function works closely with External Supply , Supply Planning, Technical support and other stakeholders involved in external supply.
Optional hybrid work model.
How you will contribute:
This person is the Quality contact for CMO(s) maintaining oversight at those CMOs for Quality related topics
Is the Quality representative on the External Supply team and works collaboratively with this cross functional team and CMO to facilitate supply of product to our patients according to Takeda SOPs and GMP standards
Prepares for and attends relevant CMO governance meetings and internal Takeda meetings. Leads applicable meetings with the CMO’s.
Resolves quality related topics and escalates where further input is required
Is the Quality contact/approver for Quality documents from CMO’s and CTL’s, as applicable.
Maintaining and improving CMO quality metrics that incorporate continuous improvement methodologies. Responsible to recommend actions as a result of such reviews / reports.
Supports internal audits and Health Authority inspections as required.
Leading or supporting CMO/ Quality projects.
Generation / review of CMO quality agreements to ensure agreements are current and within date.
Review of CMO Annual Product Quality Reviews
Support investigations into complaints as required
Support product launches activities associated with CMO’s
Represent management in meetings and cross functional teams.
Quality assurance manager oversight and approval on all applicable quality systems pertaining to CMO management including but not limited to Deviations, Change Controls, CAPAs.
Analysis of CMO management processes, development of quality improvement plans and continuous improvement.
Providing escalation, weekly updates, reports and stats to management as required
What you bring to Takeda:
Technical/Functional (Line) Expertise
Bachelor's degree in chemistry, biology, pharmacy or a related discipline
The person will have a thorough knowledge of GMPs and Quality Systems
Quality experience in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products, manufacture of biological active substances and products and manufacture of Finished Drug product.
Experience with collaborative working with Contract Manufacturing Organisations (CMO)
Experience with leading and adopting Agile and Continuous Improvement methodologies
This person will work in collaboration with the CMOs, Takeda CMO/CTL teams ,Quality teams and cross functionally with external supply, planning , technical and other stakeholders .
Good communication and interpersonal skills are required.
Demonstrates Takeda values in role
Decision-making and Autonomy
Review and approval of CMO documents
Evaluation of CMO’s Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports
Internal (including but not limited to)
Quality Leadership Team
Supply Chain & Customer Services
External Supply and Manufacturing
Pharmaceutical and Analytical Development
External (including but not limited to)
The person will manage continuous improvement initiatives in the CMO oversight team and support continuous improvement initiatives in Biologics external supply
The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at mutiple CMOs across the region
Education, Behavioural Competencies and Skills
8 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
Thorough understanding of quality systems and cGMPs.
Interpersonal skills and communication skills to interact with CMO partners and other functions.
Must be able to prioritize in a busy environment.
Must be able to travel up to 20% (domestic and international)
Must be fluent in English
What Takeda can offer you:
Full Healthcare Cover - includes dependents
Parking facilities with electric car charging points
Health & Wellness programs including onsite flu shots and health screenings
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, or any other characteristic protected by law.
LocationsIRL - Dublin - Baggot Street
Worker Sub-TypeFixed Term (Fixed Term)
Time TypeFull time
Business Area Overview
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma Collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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