Senior Manager, Clinical Quality Assurance

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose

Job Description

Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programsto drive proactive qualitymanagement, andensure compliance with corporate policies andfunctionalprocedures and applicable global regulations.

As the primary GCP quality interface cross-functionally in R&D for the product,this individualwill influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance,assessments as appropriate, design and execution of a fit for purpose audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations,andbringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.

Responsibilities

• Develop andmanageproject timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management
• Assess the success and effectiveness of the quality system and assure inspection readinessby designing an audit program ofinternal and external compliance audits and applicable assessments
• Interpret,explainand apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities
• Prioritize activities to ensureobjectivesof studies/programs are met
• Interact withDevelopmentOperations organizationand supporting functions to ensure quality compliance across allaspects of clinical development;Identify and mitigatepotential clinical quality risks and escalateto management;Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities;Provide project/program leadership in quality as a team member across clinical development functions
• Anticipate, influence, anddeterminepresent and future business needs in support of quality for adrug developmentprogram
• Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
• Identifyand implement balanced fit-for-purpose quality management;Develop and recommend strategies and tactics for success
• Identifyand remove barriers that couldimpactprogramobjectives, priorities, timelines, and quality.Communicate risks and mitigationsto management
• Serve as the primary program quality liaison during health authority inspections
  
  
  

This role can be located in North Chicago, IL, Irvine, CA, South San Francisco, CA, Worcester, MA, Dublin, Ireland or Maidenhead, UK.

Qualifications

• Bachelors degree in a physical science, life science, nursing,pharmacyor equivalent experiencerequired
• 5 years of pharmaceutical industry experience inGCPquality assurance or regulatory affairs or clinical development or clinical operations (oncology-specifica plus, but not a requirement). Prefer 1 years of GCP QA auditing experience
• Successful and progressive leadership experience in motivating teams toanticipateand deliver strong operating results, as well as to meet or exceed customer expectations.
• Problem solving abilitiesrequiredat both strategic and operational levels, ability toidentifyand resolve issues related to quality and compliance with global and local regulations, polices, and procedures.This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.
• Demonstrated ability in strategic planningand cross functional execution
• Proventrack recordutilizing core and technical competencies in managing projectsin support of clinical research
• Strong understanding of global Pharma, clinical development and operations, legal and regulatory environments
• Experience in preparing/presenting key information
• Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner
  
  
  

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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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