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Job Description

About the Role:

As part of the R&D GMP Quality team, the Principal Manager EU IMP (Investigational Medicinal Product) acts as Qualified Person (QP) in accordance with applicable regulations and provides Quality oversight and support for Takeda’s investigational medicinal product (IMP) development efforts throughout clinical development till commercialization; including different modalities and more complex internal and partnership programs.

How you will contribute:

Perform QP certification activities as set out in Article 51 of directive 2001/83 and Article 61 and 62 of CTR 536/2014 for Takeda IMPs in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations, the Product Specification File and the principles and guidelines of cGMP as laid down in Directive 2017/1572 and Delegated Regulation 2017/1569 and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products.
Oversee and conduct final release and disposition of Clinical Trial Material (CTM) including different modalities and more complex internal and partnership programs.
Depending on complexity of programs, different modalities out of Biologics, SyntheticMolecules, Plasma Derived Therapies, Cross Modality Conjugates and other new Modalities including Combination Products, requiring the interaction with several Contract Manufacturing Organisations (CMOs) or partnership companies
Batch documentation review and release activities per Takeda quality systems
Review and approve Master and Executed Batch Records and Packaging Labels.
Review and approve analytical test methods protocols, reports, specification documents, method qualifications/validations, and stability studies plan/reports as they pertain to Clinical Trial Materials.
Accountable that quality issues (deviations/events, OOX (OOT, OOL, ..), and complaints are adequately investigated and documented and provides support for the development of an appropriate corrective/preventive action plan and execution to prevent recurrence of quality issues. Collaborates with stakeholders (Pharm Science, Global Clinical Supply Chain, ..) to execute the investigaion of quality event by providing proactive support. May lead more complex regional QA investigations.
Engage cross-functionally on behalf of R&D GMP Pharmaceutical Sciences Quality to serve key business partners. Builds a good relationship with Pharm Science Team members to enhance agility for pharmaceutical development and to achieve high-quality products.
Responsible to identify applicable regulations and standards to ensures compliance with applicable regulations, cGMP and Takeda Quality standards for GMP pharmaceutical operations related to manufacturing, testing, packaging, and distribution of investigational drug product and investigational active pharmaceutical ingredients (API). Identifies compliance gaps and proposes solutions.
Provide strategic GMP quality/compliance guidance to internal stakeholders by serving as GMP QA authority on Pharm Science Team.
Provide strategic GMP guidance to third-party vendors to ensure product meets Takeda's quality expectations and compliance of Takeda products with cGMP
Supports and/or leads continual improvement initiatives in order to enhance R&D GMP Pharmaceutical Sciences Quality operating efficiencies and innovation in support of all processes involving R&D GMP Pharmaceutical Sciences Quality as responsible function. Engage cross-functionally on behalf of R&D GMP Pharmaceutical Sciences Quality to serve as key business partners.
Partner with CMC (chemistry, manufacturing and controls) submission teams to provide technical quality support for chapters of regulatory filings of assigned programs that are in responsibility of R&D GMP Pharmaceutical Sciences Quality.
Supports external auditing program. Involvment in external audits as QP to assure compliance with GMPs, regulatory filings, FDA, EU and other applicable regulatory guidelines. Leads Preapproval inspection preparation for programs/products that are assigned and supports as SME others in their activities.
Supports GMP Supplier Quality Management activities, including qualification and Quality technical Agreements including and beyond programs/products that are assigned.

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 5 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 3 year of experience as QP; IMP QP preferred
Quality auditor certification preferred.
Ability to mentor and train other team members
Comprehensive Knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry and subsequent applications to pharma drug development.
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 problem solving skills required. Ability to anticipate issues and manage a team to proactively implement solutions.
Proven organizational and communication skills required. Demonstrates and actively seeks to establish professional relationships and rapport with internal and external peers and higher-level management. Experience working on teams in a complex, matrixed and global environment. Has the ability to influence the wider organization.
Strong interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Takeda.
Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.
Share proactively professional expertise for the benefit and development of others.
High attention to detail
This role supports pharmaceutical production operations and might be conducting audits of third-party vendors, therefore the position may include exposure to production and processing facilities such as API manufacturing, pharmaceutical product manufacturing, packaging, component printing and analytical laboratories (list is not exhaustive).
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 we offer you:

A competitive remuneration package with a minimum salary of € 5.598,85 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and 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
Commuting allowance or parking space (tax applicable)
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
Employee discounts
Employee Stock Purchase Plan
Group accident insurance

More About Us:

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

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.

Make History, Change Futures.

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, the organization spans the globe—colleagues across business units and functions face challenges head-on to deliver on our vision. The omnipresent patient focus instills pride in personal contributions.

How we will support you:

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, 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. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

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Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

EU IMP Qualified Person Principal Manager (w/m/d)