Manager, QA

• Possess a strong interest in systems like Sharepoint, Quest Maps, AICE (used for hosting inspections), group mailboxes, Soltraqs/ONEtrack and work with the IM coordinator to develop processes to maintain these so that they are up to date and have the features we need to efficiently execute inspection activities.
• Manage GxP inspection activities to assure that RD quality system, GCP sponsor activities, manufacturing facilities, testing programs, clinical and pre-clinical study conduct, personnel and records in support of worldwide regulatory filings are able to demonstrate compliance to policies, procedures and applicable government regulations.
• Influence and train inspection preparation teams comprised of a variety of technical experts.
• Manage responses to health authority findings to ensure the corrective actions are robust, reviewed by appropriate leadership and submitted on time. This includes tracking all commitments to timely closure in Soltraqs
• Coordinate GxP pre-approval inspection preparation activities for AbbVie filings/products in support of regulatory filings.
• Strategize corrective action plans and provide compliance support during implementation to ensure successful inspections.
• Effectively communicate risks to management, both orally and in writing.

• Bachelor’s degree, preferably in a physical science (e.g. Chemistry) life science (e.g. microbiology or biology), computer science or pharmacy. .
• Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a regulated industry is preferred.
• Working knowledge of product development processes and systems. This could include experience in CDSO, Clinical Operations and/or medical devices.
• Working knowledge of international GXP regulations.
• Regulatory inspection experience preferably with direct agency inspector interaction..
• Strong project management skills are essential including demonstrated ability to lead a team.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
• Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgment and the ability to make difficult decisions, often at short notice.

AbbVie