Job Description Purpose Quality Assurance and Inspection Management is responsible for directing, implementing, training and providing consultation for external manufacturing/packaging worldwide.
To assure compliance with global regulatory requirements.
Responsibilities Manage GxP quality/inspection activities to assure that 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 GMP compliance and successful inspections.
Effectively communicate risks to management, both orally and in writing.
Quality Systems: Provide guidance and interpretation of QA Policies and Procedures based on applicable requirements/regulations.
Management of the external contract facilities against GxP.
In some U.S. manufacturing sites, performs batch release.
Qualifications 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.
Experience with Injectable Products. Accreditation by a professional body desirable.
Examples include American Society for Quality (ASQ) Certified Quality Manager (CQM) or Project Management Professional (PMP Certification.
Management experience, manages 1 or more Quality Specialist.
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.
Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ? ? Salary range may vary by location US and OUS.
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
This range may be modified in the future.? We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.? This job is eligible to participate in our short-term incentive programs. ? This job is eligible to participate in our long-term incentive programs? ? Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ? AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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