Senior Auditor, Supplier Audit & Compliance

Initial Therapeutics, Inc.; South Chicago Heights (IL); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie is seeking a Senior Auditor, Audit and Compliance to perform comprehensive audits for regulatory compliance across AbbVie plants, affiliates, quality service areas and suppliers, ensuring quality systems meet GMP requirements and AbbVie standards.

You will support supplier QA audits, coordinate with R&D QA and ensure timely audit execution per the annual schedule, avoiding any product launch delays.

Qualifications

• Bachelor's degree in technical/scientific area or equivalent experience (4+ years) in pharma, biotech, cosmetics or related industries.
• 9+ years total relevant experience, including 6+ years in Quality Assurance and 3+ years in compliance/auditing.
• Up to 40% travel.
• Technical understanding of QA audit processes and GMP requirements.
• Strong communication and interpersonal skills.

Responsibilities

• Assesses compliance of systems, facilities, and procedures with regulations and AbbVie specs.
• Reviews audit observations and corrective actions for effectiveness and closure.
• Coordinates supplier audits and internal site audits with stakeholders.
• Collaborates with R&D QA to plan and execute joint audits.
• Ensures audits follow the annual schedule and avoid launches delays.

Skills

Quality Assurance

Auditing

Regulatory Compliance

Project Management

GMP Regulations

Communication Skills

Education

Bachelor's degree in technical/scientific field

ASQ certification desirable

Job description

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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The function of Senior Auditor, Audit and Compliance performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Responsible for providing support to AbbVie plants in the execution of supplier Quality Assurance Audits and the resolution of CAPA plans related to supplier Quality Assurance audits. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

Responsibilities

• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.
• Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.
• Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
• For supplier auditing, primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of AbbVie plants.
• Collaborates with R&D QA to coordinate and conduct joint audits.
• Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders.
• Ensures audits are conducted according to the annual audit schedule.
• Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring of supply to AbbVie patients.

Qualifications

• Bachelors Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries. ASQ certification desired.
• 9+ years of total relevant experience, including 6+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device, biotechnology or related industry and 3+ years in compliance/auditing is required.
• Travel for this role is up to 40%.
• Must have a technical background, including an understanding of Quality Assurance audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
• Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support, and service and understand the principles of quality management.
• Excellent oral/written communications skills. Must exhibit strong interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills, and sound judgment.
• Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.

Additional Information

• 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 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 employer 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html