Vaccines External Supplier Quality Lead - Singen (Hohentwiel), Deutschland - Takeda Pharmaceutical

Takeda Pharmaceutical

Geprüftes Unternehmen

Singen (Hohentwiel), Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 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.

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

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.

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