Senior Manager, External Partners Oversight

Purpose:
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 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.
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 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).

Employment type
Full-time

Work arrangement
Hybrid