Senior GLP Auditor / Specialist

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.
Primarily responsible for providing quality consultation, training, auditing and coordination of projects
necessary to maintain and improve the quality of work-related processes and new product
development programs worldwide.

Responsibilities:

• Carry out job duties independently, including study-specific inspections, internal system / process based-audits, and external supplier CRO audits. Requires minimal supervision or direction.
• Independently plan and conduct internal systems audits, external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
• Gather internal audit metrics, perform trend analysis and present to management.
• Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
• Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
• Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
• Elevate issues to management, as necessary, in meeting these responsibilities.
• Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
• This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems, have effective interpersonal skills, work independently, mentor QA auditors, and also be an effective cross-functional team lead.

Qualifications

• Bachelor's degree, preferably in life sciences or engineering.
• Must have demonstrated strong leadership competencies, broad technical capabilities, and independence.
• 6+ years’ experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
• In-depth knowledge of global GLP/GCP regulatory standards.
• An equivalent combination of education and experience may be accepted

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• 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. ​

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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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