Overarching Project Lead (all genders) - fulltime, permanent

Unternehmensbeschreibung

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Stellenbeschreibung

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.

Ihre Verantwortlichkeiten sind:

• 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.
• 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 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).

Qualifikationen

This is how you make the difference:

• You are a Pharmacist, Chemist, Biochemist, Biologist or have a comparable background.
• You 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 achievements.
• You 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 initiatives.
• Your strong leadership skills enable you to successfully manage cross‑functional teams and also act as direct people leader.
• You are experienced with QbD‑based development approaches.

Zusätzliche Informationen

Here’s how we can move mountains together:

• with a diverse work environment where you can have a real impact.
• with an open corporate culture.
• with an attractive salary.
• with an intensive onboarding process with a mentor at your side.
• with flexible work models for a healthy work‑life balance.
• with a corporate health management that offers comprehensive health and exercise programs.
• with company social benefits.
• with a wide range of career opportunities in an international organization.
• with top‑tier, attractive development opportunities.
• with 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.