Vaccines External Supplier Quality Lead

vor 7 Monaten

Singen Hohentwiel, Deutschland Takeda Pharmaceutical Vollzeit

Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a

**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 day-to-day 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 out-of-specification 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 hands-on involvement in facilitating product inspections by global regulatory bodies, alongside a firm understanding of pre-approval 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 cross-functional projects.
- Exhibit strong organizational and planning skills along with a keen sense of urgency.

In this position you will report to the Head Vaccines Quality.

**Your **benefits**:

- Attractive and competitive salary
- Open-minded 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
- Long-term account
- Employee discounts
- Employee Stock Purchase Plan
- Company accident insurance
- Performance-related 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.

In Singen around 1,000 employees specialize in the production of liquid, semi-solid and freeze-dried pharmaceuticals. In November 2019, we inaugurated our first dengue vaccine factory worldwide here. Singen is located at the beautiful Lake Constance in Baden-Württemberg.

**How we **will support you**:
**Locations**:
Singen, Germany

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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