Manager - R&D External Partners Oversight (all genders) (full-time)

Allergan; Ludwigshafen am Rhein; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company in Ludwigshafen am Rhein is seeking a Manager for R&D External Partners Oversight. This role is pivotal in ensuring compliance and quality in R&D, working with external partners on materials and services. Candidates should have a Bachelor's Degree in a technical or scientific area and at least 8 years of relevant industry experience. The position offers an attractive salary, a supportive work environment, and opportunities for personal growth in a dynamic industry.

Leistungen

Attractive salary

Flexible work models

Comprehensive health programs

Career development opportunities

Qualifikationen

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, or Engineering or equivalent industry experience.
• Thorough understanding of international GxP regulatory standards.
• Excellent organizational and interpersonal skills.

Aufgaben

• Provide direction and execution in compliance and quality of R&D External Partners.
• Evaluate external partners for quality and compliance.
• Manage Quality Agreement life cycle.

Kenntnisse

Expertise in GXP requirements

Excellent communication skills

Team collaboration

Problem-solving skills

Ausbildung

Bachelor's Degree in technical/scientific area

Accreditation by a professional body (desirable)

Jobbeschreibung

Company Description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

People. Passion. Possibilities. Three words that make a world of difference.

More than a job. It’s a chance to make a real difference.

Welcome to AbbVie! As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrow’s unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients’ quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? You’ve come to the right place!

Together, we break through – as Manager - R&D External Partners Oversight (all genders) (full-time)

In this role you primarily provide direction and execution in compliance and quality of R&D External Partners. Also, you assure that are performed and documented in accordance with applicable worldwide quality and regulatory requirements to assure quality, effectiveness and safety of our clinical materials and drug development activities.

Additionally, you deliver relevant and constructive evaluation of external partners that provide materials and services to AbbVie R&D. This may include API suppliers, third party manufacturers, contract labs, contract research organizations, and other GXP service providers in support of ongoing development projects.

Make your mark:

• Active role expert in GXP requirements while strategically focusing on early detection and prevention, followed by correction of issues.
• Collaborate with GXP functional areas and assist in the resolution of external partner quality issues.
• Lead or participate in technically complex and strategic cross functional projects to improve compliance to regulatory requirements and standards.
• Manage the Quality Agreement life cycle and lead the creation of the Quality Agreement.
• Lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current or withdraw as applicable.
• Create a learning environment, embrace the ideas of others, and manage innovation to reality.

Qualifications

This is how you make a difference:

• Bachelor’s Degree in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
• Thorough understanding of international GxP regulatory standards (e.g., GMP, GLP, GCP, GDP, GCLP, etc.) and the audit process as well as an extensive knowledge of worldwide requirements for quality systems.
• Understanding of a variety of quality/operational systems that support study/product design, drug development, facility, production, and distribution and understand the principles of quality management.
• Excellent communications, organizational and interpersonal skills as well as an open mindedness, decisiveness, self-reliance, and sound judgement.
• Effective and collaborative working style across GXP functions, across technical areas and outside of the company.
• Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), and/or Certified Quality Auditor (CQA).
• Language proficiency in English oral and written.

What we offer you:

• 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.

At 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.

Any questions? Feel free to email us at [e-mail] – We look forward to hearing from you!

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html