Overarching Project Lead (all genders) fulltime, permanent

As Overarching Project Lead you are leading a group of highly skilled QRM experts and defining and aligning global cross-functional strategies regarding QbD and QRM development approaches. Furthermore your are representing the Drug Product (DP) team for a specific project and are responsible for activities related to drug product development and / or lifecycle management while considering legal requirements for pharmaceutical manufacturing in parenteral drug product development.

Your responsibilities are :

• Leadership of Overarching Project Group within pPDS&T Drug Product Ludwigshafen including development and alignment of overarching development strategies as well as related framework and infrastructure in strong collaboration with partners and Representation of parenteral PDS&T organization in global project teams as DP Lead
• Education and training of employees and pharmaceutical personnel in particular with regard to QbD approaches
• Responsibility in developing globally aligned standardized QRM-based development approaches for parenterals in cross functional settings.
• Development management and and guidance in the execution of global goals and initiatives to improve parenteral development and QbD strategies.
• This includes the development of technical project plans and timelines aligned with quality risk management principles effective communication of project status and risks and clear appropriate presentation of data and strategies in alignment with regulatory expectations.
• Creation and approval of GMP-compliant and regulatory documents (such as IMPD IND CTD for clinical trials and BLA NDA PAS for market submissions)

Qualifications :

This is how you make the difference :

Zusätzliche Informationen :

Heres how we can move mountains together :

Multiple times we have been globally recognized as a Great Place to Work and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality equity diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie your individual contributions count help us move mountains together. Be a part of our success grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you We look forward to receiving your application! All you need is a complete CV we will discuss everything else with you in person.

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich mit Integrität zu arbeiten Innovationen voranzutreiben Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber / Veteranen / Behinderten.

Remote Work : No

Employment Type : Full-time

Key Skills

Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture

Experience : years

Vacancy : 1