Overview
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R&D Quality Laboratory Oversight (Associate Director) – Role Summary
Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities, ensure data integrity and quality system standards in internal and external laboratories, and support regulatory submission readiness through cross-functional collaboration.
Responsibilities
* Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities.
* Ensure implementation and execution of data integrity and quality system standards in internal and external laboratories.
* Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness.
* Lead key quality initiatives and investigations related to laboratory operations.
* Provide quality oversight for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline.
* Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses.
* Ensure appropriate implementation of ALCOA+ principles and data integrity controls in laboratory systems and workflows.
* Lead or support laboratory-related investigations and inspections, ensuring timely root cause analysis and sustainable CAPA.
* Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other Quality functions.
* Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA).
* Contribute to the development and improvement of global procedures, standards, and quality frameworks for laboratory oversight.
* Monitor quality performance trends and proactively escalate compliance risks or improvement opportunities.
Qualifications
* Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field. Preferred advanced degree (MS/PhD).
* 7+ years of relevant industry experience in quality oversight of laboratory operations.
* Demonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspections.
* Strong interpersonal, project management, and problem-solving skills.
* Ability to operate in a global matrix environment and manage competing priorities.
What we offer
* 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.
* Short term incentive and long term incentive
* 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
About Takeda
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.
Locations
AUT - Wien - Industriestrasse 67
Additional details
* Worker Type: Employee
* Worker Sub-Type: Regular
* Time Type: Full time
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