- Provide strategic oversight and leadership to the network for material qualification, extractables & leachables and material implementation as business process owner
- Ensure compliance of Takeda’s material qualification, extractables & leachables and material implementation programs with applicable regulations and guidelines
- Ensure consistant practices for MQ, E&L and material implementation across the Takeda network and owns related global SOPs/standards/policies
- Responsibility for defending Takeda’s processes during inspections upon site request
- Ownership of all global SOPs/standards/policies related to MQ, E&L and material implement.
- Regular review of related GMP regulations, guidelines, standards and compendias to ensure Takeda’s processes are industry standard and in compliance
- Leading the global community of practice (CoP) for MQ, E&L and material implementation
- Support of Takeda sites with any MQ, E&L and material implementation related topics/issues
- Drive improvement in the network, specifically leading integration projects and oversee implementation of best-practices in the Takeda network
- Present MQ, E&L and material implementation processes during inspections upon request of Takeda facilities
- Support Takeda sites during all phases of material implementation
- Support departments working with CTLs (contract testing labs) and/or CMOs (contract manufacturing organizations) in regard to MQ, E&L and material implementation related topics
Your Skills and Qualifications:
- A minimum of 5 years of experience in a quality role in the pharmaceutical industry is required
- A (higher) technical/life science degree is typically required (may be substituted by experience or previous on the job training)
- Experience with raw material related processes is requirement, hands on experience in sampling, testing, release of raw materials or in material qualification/implementation is a plus
- Experience in managing global quality systems is desired
- Experience in presenting during inspections is required
- Excellent communication, interpersonal and organizational skills (German/English)
- Proactive at keeping current with literature and latest technologies
- Ability to work well both independently and in a team environment
- Ability to prioritize work and multitask
- Conducts work in compliance with cGMPs, safety and regulatory requirements
- Experience in working with strategic initiatives
As a globally leading biopharmaceutical company with the mission of “Better Health, Brighter Future”, we commit ourselves every day to service to the patients. At our core are dedicated colleagues who Takeda encourages and supports through training, job rotations and mentoring. A balanced work – life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, canteen, etc.) complete our profile as a top employer.
We offer numerous opportunities to interested people. Gender, age, skin color, background or sexual orientation play no role in this; on the contrary: We promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we ask you to declare all information relevant in this context in your application for employment.
Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications.