Senior Manager, Clinical Product Supply Quality (all genders) (full-time, regular)

Stellenbeschreibung

Welcome to AbbVie! As part of an international company with 57,000 employees worldwide and around 3,500 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? Youve come to the right place!

Together, we break through – as Senior Manager, Clinical Product Supply Quality (all genders)

Make your mark:

• Provide strategic QA oversight for assigned clinical development programs, including quality strategy, risk management, issue escalation, and executive-level communication of program status and critical decisions.
• Serve as the senior QA representative on CMC and interdisciplinary product development teams, enabling the successful progression of investigational products into clinical trials in accordance with program timelines and global regulatory expectations.
• Establish and defend risk-based quality positions for complex technical, manufacturing, analytical, supply, and compliance matters, providing clear recommendations to senior R&D leadership and cross-functional governance bodies.
• Lead the identification, assessment, and mitigation of quality and supply risks across the product lifecycle, including risks associated with drug substance, drug product, analytical testing, manufacturing, packaging, release, distribution, and clinical supply continuity.
• Provide QA leadership for internal and external integration activities, including in-licensing, collaborations, acquisitions, and onboarding of third-party manufacturers, laboratories, and service providers.
• Lead or oversee quality assessments supporting due diligence activities. Evaluate the reasonableness, completeness, quality, compliance, and sustainability of proposed plans, assumptions, controls, timelines, remediation commitments, and risk mitigations. Translate due diligence findings into actionable recommendations, including identification of material quality risks, potential value leakage, integration dependencies, required remediation, and decision points for executive leadership.
• Collaborate with partners to ensure appropriate quality agreements are established and maintained with third-party manufacturers, testing laboratories, service providers, development partners, and internal sites.
• Lead complex, global, cross-functional process improvement initiatives that strengthen clinical supply quality, operational effectiveness, compliance, inspection readiness, and organizational consistency.
• Provide oversight and direction for complex investigations, exception reports, deviations, and product quality actions, including high-impact issues affecting multiple functions, sites, products, or clinical programs.
• Provide QA oversight for clinical supply product actions, including recalls or other market and patient-impacting actions, ensuring timely, coordinated, and compliant execution.
• Support regulatory inspection and internal audit readiness and represent Quality during inspections, audits, partner assessments, and other regulatory or governance interactions.
• Build alignment across R&D, Quality, CMC stakeholders, and external stakeholders, influencing decisions at the team level.
  

Qualifikationen

This is how you make a difference:

• Bachelor’s degree in life sciences, chemistry, biology, engineering, pharmaceutical sciences, or a related discipline; equivalent experience may be considered. Master’s degree is preferred but is not required based on commensurate experience.
• 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree
• Demonstrated experience in pharmaceutical development, clinical product supply, quality assurance, GMP manufacturing, analytical testing, or related healthcare environments.
• Broad understanding of pharmaceutical manufacturing and testing processes, including chemical and biological products, investigational products, drug substance, drug product, and finished product.
• Experience supporting due diligence, in-licensing, collaborations, mergers and acquisitions, technology transfers, or post-transaction integration.
• In-depth knowledge of applicable global GMP requirements and regulatory expectations, including those of the United States and European Union.
• Quality experience leading complex, cross-functional development programs and external partnerships. Project Management Professional certification or equivalent formal project leadership experience.
• Demonstrated ability to assess complex risks, challenge assumptions constructively, and determine whether proposed quality strategies, controls, timelines, and remediation plans include robust quality and patient safety plans.
• Strong experience with issue management, investigations, exception reports, OOS/OOT, quality agreements, inspection readiness, audits, and product actions/recalls.
• Proven ability to lead through influence, build consensus, and communicate effectively with senior leadership, cross-functional leaders, external partners, and global stakeholders.
• Strong strategic thinking, judgment, problem-solving, project management, and organizational skills, with the ability to manage multiple priorities in a dynamic environment.

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 Talentacquisition.de@abbvie.com – We are looking forward hearing from you!

Zusätzliche Informationen

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.