AbbVie's quality management system needs to be sustained, improved, and globalized to support AbbVie medical devices and combination products, ensuring compliance with regulations and informing business decisions in a regulated environment.
Requirements
- Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
- Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
- Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
- Experience with FDA and other regulatory agency interactions and inspections is required.
- Familiarity with the requirements for third party external manufacturing.
Responsibilities
- Develops familiarity in both current and emerging device regulations and standards impacting AbbVie medical device and combination products, performing regulatory compliance assessments with support of senior team members.
- Supports External Audits, scribing or fulfilling auditor requests to demonstrate AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
- Will be trained to conduct Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP, with support of senior team members.
- Performs root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
- Serves as Process Owner of assigned QMS area, developing expertise in lean & six sigma methodologies for process monitoring & improvement.
Other
- Bachelor’s Degree in relevant Life Science, Engineering, or other technical discipline required.
- Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting.
- Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred.
- Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
