Director Quality and Compliance
Vor 4 Tagen
Takeda is a patient-focused company that transforms patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled professional to join our team as a Head of Process Improvement. In this role, you will be responsible for leading scientific and technical development, managing processes in purification, formulation, filling, and finishing, and supporting Takeda's mission by optimizing manufacturing processes and ensuring the highest standards of quality and compliance.
Key Accountabilities:
- Manage a team of Manufacturing Scientists and Process Validation Specialists.
- Collaborate with site operations to ensure expertise in robust and stable processes.
- Develop and implement process improvements to meet GMP Compliance, safety, and production targets.
- Maintain control over OPEX and CAPEX budgets to ensure cost efficiency and performance optimization.
- Presentation and engagement with internal and external stakeholders to promote process improvements.
Requirements:
- University degree in biotechnology, pharmaceutical sciences, or equivalent field.
- At least 10 years of experience in the pharmaceutical industry with 5-8 years in leadership roles.
- Thorough understanding of GMP requirements, Six Sigma, and protein biochemistry.
- Experience with regulatory authorities (FDA, EMA) and proficiency in Six Sigma and Lean manufacturing principles.
- Strong analytical, communication, and problem-solving skills.
- German language skills preferred, good level of English language skills is a must.
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