Director - Product Development Quality Assurance (all genders) (permanent / full-time)

Company: Allergan
Location: Lincoln
Posted on: November 4, 2024

Job Description:

UnternehmensbeschreibungAbbVie'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 .StellenbeschreibungPeople. 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 AbbVieWelcome 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 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 for 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 the 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.
• Manage 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 diligence 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 the 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 the 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 networkMultiple 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!Zus--tzliche InformationenNur gemeinsam k--nnen wir das Beste f--r Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten k--nnen - unabh--ngig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch f--r uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu ber--cksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergr--nde, Fachkenntnisse, Pers--nlichkeitstypen, Denkweisen und Lebenserfahrungen.
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Keywords: Allergan, Grand Island , Director - Product Development Quality Assurance (all genders) (permanent / full-time), Executive , Lincoln, Nebraska