Aktuelle Jobs im Zusammenhang mit Director - Product Development Quality Assurance (all genders) (permanent / full-time) - Ludwigshafen - AbbVie
-
Director - Product Development Quality Assurance
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit**Unternehmensbeschreibung** **Stellenbeschreibung** People. Passion. Possibilities. Three words that make a world of difference.** **Challenging work. Global impact. Every day.** **What makes you stand out, makes you ready to make an impact. At AbbVie** Welcome to AbbVie! As part of an international company with 50,000 employees worldwide and around...
-
Ludwigshafen, Deutschland AbbVie VollzeitStellenbeschreibungThe job that makes possibilities real in patients' lives. And yours.The job that helps you get ahead in life. Moving mountains together. 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 tomorrows unmet medical...
-
Senior QA IT Audit Project Manager
vor 2 Monaten
Ludwigshafen, Deutschland AbbVie VollzeitStellenbeschreibungPeople. 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 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs...
-
Specialist Commercial QA
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit**Gemeinsam Challenges meistern, gemeinsam Großes bewegen.** **Gemeinsam Großes bewegen heißt, Chancen zu ergreifen.** Willkommen bei AbbVie! Als Teil eines internationalen Unternehmens mit 48.000 Mitarbeiter*innen weltweit und rund 3.000 Mitarbeiter*innen in Deutschland bist Du hautnah dabei, um mit uns die gesundheitlichen Herausforderungen von morgen...
-
Associate Director
vor 3 Wochen
Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit**Company Description** Further develop your expertise and join our team as **Associate Director (all genders) Supply Chain Strategist (permanent / fulltime)**. The purpose of the role is to primarily be responsible for leadership and support of GxP supply chain strategies throughout the lifecycle of supplier including discontinuation. You will support...
-
Associate Director
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit**Company Description** Further develop your expertise and join our team as **Associate Director (all genders), GLP and Early Development Quality Assurance (permanent / fulltime).** Primarily responsible for ensuring adherence to GLP as well as GCP laboratories regulations and to assist in developing an organizational model for the Preclinical Quality...
-
Associate Director
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit**The job that makes possibilities real in patients' lives. And yours.** **The job that helps you get ahead in life. Moving mountains together.** 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 tomorrows unmet medical needs in...
-
Senior Pharmacometrician
Vor 2 Tagen
Ludwigshafen, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Post Market Quality Lab Supervisor
vor 4 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit**A career where all your skills can come into play? We Offer That.** **A task that meets your passionate approach? We Offer That.** 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 to work closely with us to address the health challenges of tomorrow....
-
Post Market Quality Lab Supervisor
vor 4 Monaten
Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit**Company Description** **Job Description** A career where all your skills can come into play? We Offer That.** **A task that meets your passionate approach? We Offer That.** 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 to work closely with us to...
-
Senior Pharmacometrician
Vor 2 Tagen
Ludwigshafen am Rhein, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Senior Pharmacometrician
vor 1 Tag
Ludwigshafen, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Senior Pharmacometrician
vor 1 Tag
Ludwigshafen, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Senior Pharmacometrician
vor 1 Tag
Ludwigshafen am Rhein, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Director (All Genders) Analytical Lead Team
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE VollzeitWelcome 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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In...
-
Director (All Genders) Analytical Lead Team
vor 3 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE VollzeitWelcome 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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In...
-
Global Quality System
vor 4 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE VollzeitWelcome 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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In...
-
Senior Pharmacometrician
vor 20 Stunden
Ludwigshafen am Rhein, Deutschland AbbVie Deutschland GmbH & Co. KG VollzeitAbbVie'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...
-
Senior Scientist I
vor 4 Monaten
Ludwigshafen am Rhein, Deutschland ABBVIE VollzeitWelcome 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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In...
-
Senior Pharmacometrician
vor 1 Woche
Ludwigshafen, Deutschland AbbVie VollzeitStellenbeschreibungWelcome 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 to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients'...
Director - Product Development Quality Assurance (all genders) (permanent / full-time)
vor 4 Monaten
People. Passion. Possibilities. Three words that make a world of difference.
Challenging work. Global impact. Every day.
What makes you stand out, makes you ready to make an impact. At AbbVie
Welcome to AbbVie As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows 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
In our Product Development QA department within Research and Development at the Ludwigshafen site, you will be working in a team of talented people and experienced experts toward developing tomorrow's products. In cutting-edge laboratories, you will be setting highest standards in the competitive field.
Moving mountains together – as Director - Product Development QA (all genders) (permanent / full-time)
Make your mark:
- Establish, maintain, and execute quality systems to ensure disposition of clinical trial supplies, including API/drug substance, ingredients, bulk drug product and finished investigational products (pharmaceutical drug products as well as drug/device combination products), testing, and related documents.
- Manages a quality organization of up to 5 direct reports and up to 50 total QA department members. Directly responsible for the effective organization, administration, training, and supervision of the Product Development Quality Organization
- Drive drug development project implementation via roles on the CMC Team or other cross-functional product sub-teams as needed to proactively avoid, manage, or address quality-related issues
- Collaborate cross-functionally (e.g., with Dev Sci, Dev Ops, Regulatory Affairs, Medical Safety, and Operations) to ensure early involvement of global key decision makers and prepare for aligned decision making
- Ensure that GMP requirements are well understood in R&D development teams, facilitate education where required
- Ensure quality and safety of IMP. Ensure compliance of IMP: pharmaceutical drug and drug/device combination products with worldwide quality and regulatory requirements and IMPD/CTA applications
- Establish and regularly evaluate quality and key performance indicators, forwarding data for management reviews and communication to business partners
- Provide management oversight of review and approval of manufacturing and analytical batch records, exception reports, OOS reports, and changes in the quality system,
- Responsible for Quality Management in pilot plants and labs
- Ensure that EU GMP requirements are appropriately addressed in collaboration processes (e.g. global product supply chain, QP role, execution of the Quality System) and in the respective Technical Quality Agreements (TQAs)
- Ensure suitable quality agreements or quality aspects of contracts for GMP-controlled activities are in place between R&D and third-party manufacturers, third-party labs, other service providers, customers, and other sites
- Support integration of acquisitions and perform GMP assessment of due diligences or in-licensing activities
- Develop a risk-based approach for decision making and support continuous improvement via development of cost-efficient processes at sites, and collaboration between sites to optimize global processes and share best practices
- Advance local and global initiatives on continuous improvement and strategic initiatives in areas of responsibility
Qualifikationen
- Bachelor’s Degree, or equivalent work experience, required in Pharmacy, Chemistry, Biology, or Microbiology. Master’s Degree or PhD preferable
- Expertise as a Qualified Person (QP) pursuant to Article 15(1) of the German Drug Law (Arzneimittelgesetz, AMG) and multi-year practical experience as QP preferable
- At least 10 years of experience in the pharmaceutical industry, should include roles in Quality Assurance and experience in manufacturing, finishing, or testing of medicinal products. Experience in an R&D environment and with Investigational Medicinal Product preferred. 5+ years of management experience, preferably direct management
- Thorough understanding of the pharmaceutical product development cycle and expert knowledge of worldwide regulatory requirements and GMPs. Considered a Subject Matter Expert and key contributor to initiatives and advancement of the Quality organization
- Must be able to make critical, creative, and strategic decisions as a result of rapid analysis of available information. This must include thorough risk-assessment for the patient and for the business
- Skilled in the initiation, selection, coordination, and management of projects and have ability to resolve complex technical problems by providing innovative solutions. Must be able to formulate decisions and approaches in the complex environment of global investigational material supply chains with all of the business partners and interested parties involved (R&D, Operations, TPMs and TPLs, affiliates, service providers, etc.)
- Must have strong leadership skills, take positions on Quality issues and standards, and be capable of clearly and logically justifying such positions, both internally and externally
- Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills required to interact with and have ability to influence decisions of senior management in all areas
- Excellent knowledge of both written and spoken English
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.
Any questions? Feel free to email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you
Zusätzliche Informationen
Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können – unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.
