Vaccines External Supplier Quality Lead
vor 1 Woche
Vaccines External Supplier Quality Lead (all genders)
Join us as a crucial participant and vital contributor to our bold and inspiring mission: Better Health, Brighter Future.
In this role, you will play a pivotal role in offering guidance and leadership in quality aspects to ensure that the external suppliers' operational vaccine activities align with cGMP requirements and fulfill Takeda's expectations.
Your main responsibilities:
- Manage daytoday interactions with CMOs to ensure consistency in achieving product quality and compliance across multiple CMOs, external suppliers and global markets. Support operations at internal sites.
- Lead the External Supplier Quality Assurance team and guarantee timely and compliant execution of quality processes such as document review and approval, investigations and change controls.
- Conduct thorough investigations into issues related to audits, manufacturing and complaints. Authorize deviations in manufacturing and testing, as well as investigations into outofspecification results. Ensure definition of effective CAPAs and track their timely implementation.
- Review and approve documentation for tech transfer and validation of analytical methods and manufacturing processes.
- Support CMOs during regulatory inspections, perform audits and provide support with regulatory submissions.
Your Profile:
- Hold a Bachelor's degree or higher in Chemistry, Microbiology or Biological Sciences or an equivalent scientific discipline.
- Possess a minimum of 6 years of quality assurance experience in pharmaceuticals/biologics as well as experience with Good Manufacturing Practices.
- Exhibit a demonstrated grasp of US, European, and global cGMPs, compliance challenges, inspection tendencies, and prevailing quality assurance practices within the industry.
- Possess handson involvement in facilitating product inspections by global regulatory bodies, alongside a firm understanding of preapproval inspections and product market introduction Showcase adept leadership abilities, enabling effective team management.
- Demonstrate assertiveness, exceptional negotiation skills, tactful demeanor during negotiations as well as leadership attributes, showcasing adaptability to virtual teams and crossfunctional projects.
- Exhibit strong organizational and planning skills along with a keen sense of urgency.
Your benefits**:
- Attractive and competitive salary
- Openminded and modern working environment
- Hybrid working model
- 30 vacation days
- Company pension plan
- Further education and training
- Travel allowance for public transport
- Subsidized canteen
- Subsidized sports programs
- Disability insurance
- Longterm account
- Employee discounts
- Employee Stock Purchase Plan
- Company accident insurance
- Performancerelated bonus
- Trusted working hours
- Employee Referral Program
- Deferred compensation as desired
- Global Wellbeing Program
- Childcare
- Employee Recognition Program
About Us:
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
How we will support you**:
Locations:
Singen, Germany
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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