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Allergan Aesthetics, an AbbVie Company · 1 day ago

Senior Manager - RDQA External Partners Oversight (ExPO)

North Chicago, IL, USA

Full-time

Hybrid

Senior Level, Lead/Staff

8+ years exp

Allergan Aesthetics, an AbbVie Company, is dedicated to discovering and delivering innovative medicines and solutions. The Senior Manager will provide leadership and direction for compliance with regulatory requirements and evaluate clinical external suppliers to ensure quality and safety in drug development.

BeautyManufacturingPharmaceuticalWellness

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 Clinical Quality Agreement life cycle; lead the creation of the Clinical Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Clinical Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Clinical Quality Agreements, as applicable

Provide an active role within R&D as an expert in GCP 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

Qualification

GCPSupplier oversightQuality managementRegulatory standardsTechnical backgroundCommunication skillsLeadershipInterpersonal skillsOrganizational skills

Required

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 clinical, e.g. GCP, international regulatory standards

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