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Sr. QA IT Audit Project Manager (Remote)

Employer
AbbVie
Location
North Chicago, IL
Start date
Apr 17, 2024

View more

Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details


Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.


Job Description

Come to work each day with an inclusive and collaborative business technology team. As a Senior IT Audit Project Manager in AbbVie Business Technology Solutions (BTS), youll have opportunities to contribute to the digital transformation of a leading biopharma company,helping to create solutions that impact patients and their communities for the better.

This position can be remote anywhere in the U.S.

Our Business Technology Solutions (BTS) team shapes the digital transformation accelerating the future of medicine at AbbVieand we do it together, asking bold questions and taking on tough challenges through deep, honest collaboration. In the role of IT Supplier Audit Project Manager, you will join a diverse, global team that invests in your customized career growth and uses technology and data to positively impact peoples lives.

The function of the IT Audit Project Manager is to perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide services and products to AbbVie. Suppliers can include third-party IT system and Services suppliers. Their execution in GXP 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.

  • Assess compliance of systems, services, facilities, and procedures per applicable regulations through audits and assessments of our GxP IT suppliers, assuring compliance to regulatory requirements and AbbVie specifications.

  • Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.

  • The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

  • Participate in strategic initiatives to improve compliance to regulatory requirements and standards.

  • Execution of audits and assessments assigned and manages relationships with management of auditees.

  • Operates independently to prepare relevant audit summaries of key issues for audits supported.

  • Leads coordination across multiple audit teams, including AbbVie and future acquisition audit teams to ensure consistency for scoping, audit procedures performed, documentation, reporting and issue resolution.

  • Executes audits and related follow-up as assigned.

  • Leads ad hoc analysis, projects and process improvements as needed.

  • May have supervisory responsibility for one or more direct reports.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


Qualifications
  • Bachelors Degree and 7 years experience OR Masters Degree and 6 years experience OR PhD and 2 years experience

  • Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GXP 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.

  • The individual must have excellent oral/written communications skills.

  • Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.

  • 2+ years in Quality Assurance with project management experience and compliance/auditing or regulatory affairs knowledge.

Why Business Technology Solutions

For anyone who wants to use technology and data to make a difference in peoples lives, shape the digital transformation of a leading biopharmaceutical company, and secure sustainable career growth within a diverse, global team: were ready for you.


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.
  • 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 Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

Company

AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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