AbbVie Area Manager (JAPAC) in Sydney, Australia
Area Manager (JAPAC)
Australia, New South Wales, Sydney
1 additional location
Australia, New South Wales
Manage GxP inspection activities to assure that R&D quality system, 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.
Coordinate GxP pre-approval inspection preparation activities for contract facilities utilized 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.
Quality Systems: Provide guidance and interpretation of Affiliate QA Policies and Procedures based on applicable requirements/regulations
Management of the global AbbVie R&D self-inspection program including organization of the global, internal audit schedule
Bachelor’s degree, preferably in physical science (e.g. Chemistry) life science (e.g. microbiology or biology) or pharmacy. Strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
Accreditation by a professional body desirable. Examples include American Society for Quality (ASQ) Certified Quality Manager (CQM) or Project Management Professional (PMP Certification.
Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a regulated industry required. Experience in two or more of the following areas: Clinical Operations, Pharmacovigilance, manufacturing/testing of sterile dosage forms, biologics, liquids, solid dosages, active pharmaceutical ingredients or medical devices.
Thorough, documented understanding/knowledge of international GXP regulations. Knowledge of pharmaceutical drug development and clinical research processes.
Regulatory inspection experience preferably with direct agency inspector interaction.
Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
Strong project management skills are essential.
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.
Job Type: Experienced