Senior Manager, External Partners Oversight

BioSpace; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) plan

Paid time off

Job summary

AbbVie is seeking a senior professional to lead compliance for worldwide supplier materials and services, ensuring quality and regulatory adherence across medical devices and drug development. This role provides leadership in evaluating external suppliers, implementing Quality Agreements, and guiding R&D on GXP requirements.

You will collaborate across RDQA and other functional areas, drive continuous improvement, and manage metrics for External Partners Quality while upholding AbbVie's

Qualifications

• Bachelor's degree in technical or scientific area or equivalent experience (8+ years) with exposure to medical device or combination product industries.
• Understand international regulatory standards and GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations.
• Technical background with knowledge of supplier oversight.
• Familiarity with quality/operational systems supporting study/product design and device development.
• Strong communication, leadership, judgment, and organizational skills.
• 8+ years in QA/Regulatory Affairs, healthcare or related fields; ASQ certifications desirable.

Responsibilities

• Oversee supplier compliance programs and conduct evaluations.
• Interpret and apply regulations, policies, and guidelines for activities.
• Lead Quality Agreement lifecycle, reviews, and terminations as needed.
• Act as R&D expert in GXP requirements.
• Collaborate with R&D to resolve external supplier quality issues.
• Prioritize activities to meet study and program objectives.
• Lead or participate in cross-functional, strategic projects.
• Improve regulatory compliance initiatives and standards.
• Balance involvement with independence and objectivity.
• Collect and report metrics on External Partners Quality.
• Demonstrate AbbVie's Ways of Working and leadership; foster learning and innovation.

Education

Bachelor's degree in technical or scientific field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering)

Excellent oral/written communications

Interpersonal skills

Leadership qualities

Persuasive, cross-functional collaboration

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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 objective.
• 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

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 Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligible employees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis 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 employeeremainsin the Company's sole andabsolute discretion unless and until paid andmay be modifiedat the Companys sole and absolute discretion, consistent withapplicable 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