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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

This role is based at our North Chicago, IL headquarters 3 days weekly.

Purpose:

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.

Responsibilities:

• 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

Qualifications:

• 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).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​​

• This job is eligible to participate in our long-term incentive programs. ​

​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

​

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.