Quality Manager, Quality CMO oversight

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Job Description

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

Leadership

• 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

Interaction

Internal (including but not limited to)

• Quality Leadership Team

• Disposition Team

• Technical services

• Supply Chain & Customer Services

• External Supply and Manufacturing

• Regulatory Affairs

• Pharmaceutical and Analytical Development

• Process Development

External (including but not limited to)

• Contract Manufacturers

Innovation

• The person will manage continuous improvement initiatives in the CMO oversight team and support continuous improvement initiatives in Biologics external supply

Complexity

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

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

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.

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