About this role
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 LeadEducation and training of employees and pharmaceutical personnel in particular with regard to QbD approachesResponsibility 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) This is how you make the difference:
You are a Pharmacist, Chemist, Biochemist, Biologist or have a comparable backgroundYou preferably have a PhD and at least 8 years of experience in relevant areas of parenteral Drug Products, as well as a proven track-record of advanced technical/scientific achievementsYou possess the required knowledge of current regulations, guidelines, and the competitive landscape and are capable of working in a fast-paced, collaborative environment overseeing multiple projects and initiativesYour strong leadership skills enable you to successfully manage cross-funtctional teams and also act as direct people leader You are experienced with QbD-based development approaches
Here's how we can move mountains together:
with a diverse work environment where you can have a real impactwith an open corporate culturewith an attractive salarywith an intensive onboarding process with a mentor at your sidewith flexible work models for a healthy work-life balancewith a corporate health management that offers comprehensive health and exercise programswith company social benefitswith a wide range of career opportunities in an international organizationwith top-tier, attractive development opportunitieswith a strong international network
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.