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.

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Job Description

Further develop your expertise and join our team as Sr Manager (all genders), Supplier Management (permanent / fulltime).

Primarily responsible for providing leadership and direction and ensuring compliance with worldwide regulatory and AbbVie outsourcing requirements; providing relevant and constructive evaluation of external suppliers that provide materials and services to AbbVie for use in Research & Development.

Provides leadership, direction, and execution in compliance and quality; ensures that activities are performed and documented in accordance with applicable worldwide quality, regulatory and AbbVie requirements to assure quality, effectiveness and safety of our medical device, clinical materials, and drug suppliers.

This means

• With a focus on medical device suppliers, assess compliance to applicable regulations (e.g., IVDR, MDR) through supplier oversight activities. The strategic focus is for early detection and prevention, followed by correction of issues.

• Provide an active role within R&D supplier quality as an expert in medical device requirements for external suppliers.

• Interpret, explain, and apply governmental regulations, guidelines, policies, and procedures applicable to associated activities.

• Collaborate with R&D functional areas and assist in the resolution of external medical device supplier quality issues.

• Prioritize activities to ensure objectives of studies/programs are met. Maintain project oversight to include awareness of project timeliness.

• Lead or participate in technically complex and strategic cross functional projects.

• Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.

• Achieve a difficult balance of involvement, independence, and objectivity.

• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality.

Qualifications

This is how you can make a difference:

• Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to medical device or combination product related industries.

• Thorough understanding of international medical device regulatory standards (e.g. MDR, IVDR, ISO, FDA, etc.). Understanding of GxP (GMP, GLP, GCP, GDP, GCLP) preferred.

• Must have a technical background and requires a thorough understanding of the supplier oversight and an extensive knowledge of worldwide requirements for medical device quality systems.

• Must understand a variety of quality/operational systems that support study/product design, device development and understand the principles of quality management.

• Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment.

• Persuasive, effective communication skills are essential with an ability to work effectively across RDQA functions, across technical areas and outside of the company.

• 8+ years of experience in function or related fields, such as Quality Assurance/Regulatory Affairs, pharmaceutical/device/healthcare industry, compliance/auditing experience (preferred) and/or laboratory experience (preferred).

• Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA).

What we offer you:

• a diverse area of work where you can make a real difference

• an open company culture

• attractive remuneration

• intensive onboarding by a mentor

• flexible work models for a healthy work-life balance

• corporate health management with comprehensive health and exercise programs

• corporate social benefits

• diverse career options in an international organization

• high-level, attractive career development opportunities

• a strong international network

  At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond! Sounds like the perfect career opportunity for you? We look forward to receiving your application. All you need is a complete CV – anything else will be discussed in person, where possible, if general suitability is determined.

At AbbVie, your individual contributions count – help us achieve more together. Be a part of it and grow with us – go above and beyond!

Have questions? Email us at TalentAcquisition.de@abbvie.com – we look forward to hearing from you!

Additional Information

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.