Assoc Dir - Research Quality Assurance Lead (f/m/x)


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Job Description

About the role:

The Assoc Dir Quality Assurance is in charge of maintaining and supporting the quality oversight of the GLP & GCLP QA program of Takeda´s GLP Test Facility in Vienna and the QA oversight of GLP regulated activities in R&D. Additionally he will support non-GxP R&D areas and provide Quality oversight for submission relevant activities/data.

How you will contribute:

  • Provide GLP and GCLP quality oversight and ensure a state of compliance within the GLP test facility Vienna

  • Perform protocol, study phase, raw data, amendment and final report reviews and audits of non-clinical virus reduction studies conducted in compliance with international and domestic GLP and OECD GLP regulations

  • Perform internal process and facility based audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance

  • Review and audit compliance documents, SOPs, and protocols in support of GLP test facility regulated activities

  • Maintain GLP training program to ensure that personnel are appropriately trained to carry out GLP responsibilities

  • Participate in regulatory inspections, inspection readiness activities and agency inspections as needed

  • Support implementation of GLP test article testing in R&D non-GxP labs

  • Audit CoTs of GLP test articles

  • Perform protocol and Data Integrity reviews, assessments and audits

  • Lead internal and external (supplier) quality audits to assess quality management systems, adherence to applicable regulations/procedures and appropriateness for use by quality standards

  • Establish and maintain relationships with Research QA stakeholders to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs

  • Support implementation of GLP test article testing in R&D non-GxP labs

  • Audit CoTs of GLP test articlesProvide subject matter expertise to R&D stakeholders and advise on quality and compliance related issues

  • Perform protocol and Data Integrity reviews, assessments and audits

  • Support other quality GLP and QMS related activities as assigned

  • Assist in the data collection for key performance indicators (KPIs) and quality metrics for quality to drive process

  • Ability to identify creative solutions to complex problems (Complexity: Products managed, mix of businesses, internal and/or external business environment, cultural considerations

What you bring to Takeda:

  • Minimum of a Bachelor's degree in a scientific field

  • At least 7 years of experience in GLP compliance/ QA within a pharmaceutical or biotech industry environment

  • Previous working experience in internal/ external domestic and international GLP auditing required

  • Analytical auditing background desired

  • Strong experience in CS validation 

  • Good knowledge of international regulatory requirements and industry guidelines for global GLP and data integrity

  • Ability to identify issues and offer solutions in a pragmatic way

  • General knowledge of drug development process

  • Excellent written and verbal communication skills in German and English

  • Excellent business skills such as critical thinking, strategic planning, and self-management

  • Mature, problem solving attitude, exhibits judgment and realistic understanding of the issues; able to use reason even dealing with emotional topics and have the interpersonal skills to deliver tough messages

  • Understanding objectives and processes across R&D and corporate functions and when escalation is necessary

  • Collaborative team player with a positive attitude who can think and act quickly

  • A self-starter, who motivates, has tact and diplomacy, and can define and prioritize tasks within a project•

  • Decision-making and autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

  • Ability to take a big-picture approach to decision-making based on sound principles and compliance knowledge

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.

Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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