AbbVie

Principal Quality Engineer

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Aug 19, 2020
Ref
2006022
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
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 , YouTube and LinkedIn .

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Accountable for leading quality of project documentation to meet Abbott policy requirements and all applicable federal regulations. Establishes quality system requirements for an IT environment. Leads cross-functional teams.
  • Provides program management for regulatory project initiatives (SOX, Part 11). Analyze and specify the staffing needs for a project or program.
  • Provides project quality leadership for validation or SDLC activities including: Represents as signatory responsible for IT projects to assure compliance (Sign as Quality Manager for validation review board meetings), Manage SDLC process to maximize product quality and minimize costs to clients and QA team, Recognize priorities, dependencies, and critical paths that are important to the sequencing of project activities and manage to successful resolution.
  • Responsible for creating and applying risk based approach strategies by preventing problems from occurring to the greatest extent possible. Solve problems quickly, effectively, and cost-efficiently. Recommend system release readiness and approve key project deliverables that are approved by peer managers and reviewed by regulators.
  • Serves as expert division resource with regards to quality systems and compliance issues, helps to evaluate system (applications, layered software, & hardware) implementations or changes for impact on other systems. Perform lead auditor responsibilities for internal and supplier audits. Participate and lead internal CIT and cross-divisional audit teams for external IT supplier audits. Follow up on audit observations/findings until they are closed.
  • Determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained. Provides leadership for QA initiatives, including policy, processes and procedure updates and implementation, cross-divisional consistency, and cross-program consistency.
  • Develop and maintain written policies, processes, and procedures related to the SDLC and auditing requirements. Responsible for collating, reporting, and presenting to senior staff; process improvements, metrics, audit observations and analysis, and adherence to defined Abbott practices.
  • Provide training and/ or training materials that support the SDLC process and audit preparedness. Manage daily activities for direct reports or supervise the work of indirect project resources.
  • Responsible for review and approval of audit observation responses

Qualifications
  • B.A. or B.S. in engineering or computer related field or equivalent experience plus technical experience. MBA a plus.
  • Minimum overall experience 7 years, to include two of the following areas: Experience in a formal software development life cycle (9-15 years). Experience in regulated software environment. (3-9 years) Software Quality experience (3-5 years) , Project Management in software experience (3-5 years). Auditing Experience (2-3 years). Quality Systems experience (3-5 years).
  • US regulations (GMP parts 11, 58, 210, 211, and 820). ASQ Certified CQA/CSQE preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.