Quality Assurance Manager (f/m/x)


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Job Description

About the role:

The core purpose of the Quality Assurance Manager within External Supply Plasma Quality (ESPQ) is to oversee Contract Manufacturing Organization (CMO) operations performed on behalf of Takeda and to support above-site activities including quality representation in projects.

How you will contribute:

  • Support and coordinate disposition activities of commercial and clinical products including batch record review

  • Manage quality activities with CMO-partner oversight to assure operational activities and product release (intermediate, drug product and finished product) and compliance of CMO with GMP regulations and license registration of Takeda Plasma Derived Products

  • Support any GMP, quality or compliance activities

  • Lead above-site activities and projects within the Plasma OpU

  • Support inspections by CMO or by Regulatories authorities

  • Support global requests of Quality Metrics / KPIs for ESPQ team

  • Support complaints management

  • Support Global Drug Safety for the adverse events (AE) cases trend analysis when applicable

  • Manage deviations with CMOs and/or with Takeda and change control records for ESPQ products

What you bring to Takeda:

  • Bachelor’s Degree in BS in engineering or equivalent technical disciplines

  • Minimum of 5 years of experience, working within a regulated healthcare industry in a Quality Assurance, Quality Control and/or Quality Compliance role

  • Expert knowledge GMP and plasma related regulations knowledge

  • Leadership personality with strong project management skills

  • Expertise in operational excellence and/or automation experience is a plus

  • Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred

  • Green Belt or Black Belt certification; Auditor certification highly preferred

  • Profound knowledge of computerized systems (MS Office, ERP, SQL*LIMS)

  • Ability to work under pressure and to keep track of tasks and priorities

  • Excellent command of the English and German language (verbal and written)

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 4 527,78 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
  • Work @ home depending on the position / department
  • Comprehensive training programs
  • In-house job rotation program
  • In-house Canteen with discounts or meal vouchers
  • Works council (events, festivals, shopping vouchers, etc.)
  • Employee Referral Program
  • Employee Recognition Program
  • Takeda Resource Groups
  • Medical checkups
  • Free vaccination program
  • Fitness Center
  • In-house cleaning service

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.

Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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