AbbVie

R&D Quality Assurance, Project Manager

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 13, 2020
Ref
2008407
Required Education
High School or equivalent
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 .

*As an organization, RDQA resides in Head Quarters North Chicago, IL USA, Ludwigshafen Germany, Maidenhead, UK, and Tokyo, Japan as primary locations with specific GXP roles*

The R&D Quality Assurance, Project Manager serves as an operational partner who leads multiple business process programs and projects. Ensures smooth logistical support of department projects, RDQA assets programs, initiatives, and priorities. Key contribution to end-to-end project/program objectives, outcomes, strategic alignment, and communication to senior leaders and cross-functional decision-making committees. Develop and manage key project artifacts such as project charters, status reports, work plans, stakeholder engagement plans and decision-making models. Support cross-functional risk identification and mitigation process related to pipeline product development. Provide guidance to QA functions to support definition of program level risk and associated mitigation strategies.

Key Responsibilities:
  • Provides project management support for functional projects as needed: Prepares status reports and dashboards using standard templates, tracks risks and mitigation plans; tracks issues and facilitates resolution; schedules team meetings; establishes agendas, keeps minutes, manages timelines, creates deliverables and gains approvals, manages artifacts of historical documents);
  • Manages and support the creation of process deliverables (tracking spreadsheets, business cases, PowerPoint summary and visuals).
  • Maintains, adapts, socializes, and shepherds the resource needs based on AbbVie Pipeline during financial cycles and acquisition planning.
  • With direction from RDQA Director and/or Assistant Director, responsible for completing cross functional projects and strategic initiatives related to RDQA Business Management deliverables. Gains buy-in from management and other parties, as appropriate.
  • Responsible for suggesting process efficiencies related to their business operations area and contributes to the identification of gaps. May be assigned to lead change efforts to current process with a focus on continuous improvement to support and build culture.
  • Provides input to procedures and work instructions to support the vision and strategy for to their specific business operations area. Create/maintain process flow diagrams depicting activities. Develops and delivers relevant training to Business Owners, Vendors, and other appropriate parties.
  • Possesses a working knowledge of each of the RDQA GXPs and functions. Demonstrates knowledge of the product life-cycle business processes, and regulations in the RDQA functions. Works with management to develop long-term strategies for business performance optimization. Establishes effective working relationships with peers and stakeholders across related and partner functions such as Clinical Operations, Clinical Development, Clinical Supply, Inspection Management, Operations QA, IT, vendors, etc.
  • Demonstrates knowledge in utilizing multiple systems/software tools (QUANTUM, SolTRAQS, Spotfire, Excel, PowerPoint, SharePoint,) to capture, read, analyze, and report pertinent data.

Qualifications

Qualifications:
  • High School diploma or equivalent and 12 years' experience or bachelor's degree required. Bachelor's degree preferred.
  • Project Management Certification a plus (e.g. Project Management Institute (PMI) Project Management Professional (PMP) certification preferred.
  • 3 years pharma, health care or industry related experience preferred.
  • Minimum of 6 years project planning and management experience including successful implementation of business and/or technology initiatives preferred.
  • Proven leadership skills and presence required.
  • Experience working in a complex and matrixed environment required. Strong interpersonal, and communication skills with the ability to influence, builds relationships with peers and cross-functionality at both global and local levels to drive performance
  • Robust communication skills both oral and written required. Ability to craft compelling business cases and sell new ideas preferred.
  • Experience analyzing complex business problems and facilitating the design of innovative solutions preferred.
  • Ability to travel as needed to various regional and global locations (up to 15%)
  • Broad experience in business operations role preferred.
  • The incumbent must be agile and able to respond rapidly to unplanned events, changing needs of development programs as well as changing regulatory requirements and expectations

Key Stakeholders:
All R&D QA functions, Site Management & Monitoring (SMM), Regulatory Affairs, Clinical Development, Pharmacovigilance & Patient Safety (PPS), Operations QA

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
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.