Senior Manager, External Partners Oversight

BioSpace; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Long-term incentive program

Job summary

AbbVie seeks a senior regulatory and supplier quality leader to oversee compliance with worldwide quality standards for external suppliers supporting medical devices, clinical materials, and drug development programs. You will provide leadership and evaluations to ensure quality, safety, and regulatory alignment across the supply chain.

Responsibilities include managing Quality Agreement lifecycles, cross-functional reviews, and guiding R&D in GXP requirements, while detecting issues early and

Qualifications

• Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (8+ years).
• Thorough understanding of international regulatory standards, GxP and Medical Device regulations.
• Must have a technical background and understanding of supplier oversight.
• Experience with quality/operational systems supporting study/product design and device development.

Responsibilities

• Assess compliance with regulations through supplier oversight activities and early issue detection.
• Interpret and apply current governmental regulations, guidelines, policies, and procedures.
• Manage Quality Agreement lifecycle and lead cross-functional reviews and terminations as needed.
• Provide active role within R&D as an expert in GXP requirements.
• Collaborate with R&D to resolve external supplier quality issues and drive improvements.
• Prioritize activities to meet study program objectives and maintain project oversight.
• Lead or participate in cross-functional, strategic projects and initiatives to improve regulatory compliance.

Skills

Quality/regulatory knowledge

GxP familiarity

Supplier oversight

Leadership

Communication skills

Analytical skills

Education

Bachelor's degree in technical or scientific field

Tools

Quality Management System (QMS)

Job description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Purpose

Job Description

Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of external suppliers that provide materials and services to AbbVie.

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

Responsibilities

• Assess compliance with applicable regulations through supplier oversight activities. The strategic focus is for early detection and prevention, followed by correction of issues.
• Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures as applicable to associated activities.
• Manage Quality Agreement life cycle; lead the creation of the Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable.
• Provide an active role within R&D as an expert in GXP requirements.
• Collaborate with R&D functional areas and assist in the resolution of external 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.
• Collect, analyze, and report metrics pertaining to External Partners Quality.
• Consistently demonstrate AbbVies 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

• Bachelors 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 regulatory standards. Understanding of GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations and standards preferred.
• Must have a technical background and a thorough understanding of the supplier oversight.
• 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

• 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 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 employer 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html