Takeda Pharmaceutical Vienna Austria
1 month ago
About the role:
The Pharmaceutical Science Quality Associate Director IMP QPs acts as Qualified Person (QP) in accordance with applicable regulations and provides strategic, industry-leading Quality oversight and support of Takeda’s investigational medicinal product (IMP) development efforts throughout clinical development till commercialization for all modalities and internal and partnership programs of all complexities.
How you will contribute:
• Provide strategic leadership and oversight to the team of IMP QPs regarding managed projects/programs.
• Accountability for the performance and results of a team of IMP QPs... ensuring appropriate training, qualifications, and continuous professional development.
• Responsible to appoint his/her direct reports as IMP QP representatives to Pharmaceutical Science Team, and provides strategic direction to support pharmaceutical development and supply chain of investigational medicinal product.
• Provides members with his/her sufficient experience and knowledge but also strategically give them challenges to help them grow with appropriate advice when necessary.
What you bring to Takeda:
• Eligibility to act as Qualified Person in line with local and EU directives
• Majored or worked in the field of Pharmacy, Chemistry, Biology, Engineering or related field. Bachelor’s Degree required; advanced degrees preferred.
• Minimum of 7 years of increasingly responsibility and experience in pharmaceutical manufacturing, packaging, laboratory or QA/QC/Compliance environment.
• Experience in QA/QC/Compliance environment preferred.
• Minimum of 5 year of experience as QP; IMP QP preferred.
• Quality auditor certification preferred.
• Demonstrated ability to effectively lead, motivate and develop a team of direct reports through mentoring and identifying and leveraging opportunities for learning and growth
• In depth knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry and subsequent applications to pharma drug development. Allowing to contribute in Takeda initiatives to evaluate and comment on Concept Paper and revision of regulatory Guidelines.
• Proven ability to critically evaluate completed manufacturing documentation and assess to determine compliance with Regulations, procedures, regulatory filings and clinical trial authorizations.
• Demonstrated teamwork, initiative, and advanced problem solving skills required. Ability to anticipate issues and manage a team to proactively implement solutions. Ability to make informed decisions and respond rapidly to emerging quality situations.
• Excellent interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Takeda
• Proven ability to negotiate difficult issues and arrive at mutually beneficial solutions.
• High attention to detail
• Routine demands of an office based environment; i.e. be seated at a desk and perform document/data review.
• Requires approximately 10% travel, including domestic and international flights with overnight stays.
• Must be able to read, understand, speak and write technically and legibly in English
What Takeda can offer you:
A competitive remuneration package with a minimum salary of €4.751,92 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
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.
AUT - Wien - Industriestrasse 67
Associate Director, IMP Qualified Person Lead (w/m/d), Hybrid Vienna jobs
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