Manager Global Standards

Vor 2 Tagen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
**J**oin our team as we oversee and elevate the quality and lifecycle management of Standards & Reagents (S&R) for Takeda products. In this role, you'll lead global initiatives to monitor compliance and drive continuous improvements, manage stability studies for various drug entities, offer expertise through training and best-practice sharing across the Takeda network, and be the champion in defending our processes during external inspections. Be at the forefront of ensuring excellence in product quality and reliability.**:
**How you will contribute**:

- ** Advance and drive** cross-functional processes regarding S&R management globally.
- ** Lead** global and cross-functional investigations and technical problem-solving activities.
- **Organize** a continuous supply of S&R by controlling inventory, and planning and organizing replenishment activities.
- **Manage** stability studies for Plasma Derived Therapies and Hematology Products, ensuring correct and prompt execution of both routine and specialized stability programs.
- **Authorize** technical documents essential for regulatory submissions.
- **Contribute actively** to the preparation of internal audits and on-site regulatory inspections.
- **Consider** all relevant aspects, understanding the impact on patients, GMP regulations, the supply chain, and the business.
- **Support** Takeda sites with any S&R or stability-related inquiries throughout all product development and implementation phases.
- **Drive** improvements across the network, especially in integrating and refining stability processes to best meet business needs.

**What you bring to Takeda**:

- A (higher) technical/life science degree is typically required (may be substituted by experience or previous on the job traning)
- You have a minimum of 5 years of experience in the pharmaceutical industry (preferably quality role) and a minimum of experience in leading projects (preferably global projects).
- Experience in standards & reagents related processes and/or product stability programs.
- You have experienced a leading role in global and cross-functional projects.
- You are knowledgeable with ICH and other regulatory requirements is desired.
- Experience in managing global quality systems and th ability to author technical documents is preferable.

**Technical Knowledge**:
Very good understanding of standards, reagents life cycle, and product stability. Experience in planning standards and reagents supply and managing product stability studies.

**Leadership Skills**:
Proven project and team leadership, including managing cross-functional and global teams. Strong communication abilities to articulate technical matters to all stakeholders. Efficient in escalation procedures when needed.

**Decision-making & Autonomy**:
Ability to independently decide on project timelines, team formation, and technical aspects. Skilled in making decisions on stability study execution, ensuring alignment with organizational objectives, and crafting strategies compliant with internal and external regulations.

**I**nteractions**:
Proficient in fostering inter-departmental communications, maintaining robust relationships with customers, experts, regulators, and suppliers, and representing the organization in external forums when necessary.

**Innovation**: Capable of developing and adapting strategies for S&R life cycles in line with global regulations and organizational needs. Comprehensive knowledge of the role and implications of lab materials like reference standards and critical reagents in analytical methods.

**Complexity**: You will be supporting all Takeda Operating Units, including Biologics, Plasma, Vaccines, and Small Molecules. Therefore, being familiar with the complete product life cycle from production to discard is essential. You are comfortable working in a global environment.
- Family-friendly company environment; Support with parental leave, dad month, bilingual company kindergarten.
- 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 commitme

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