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Function: QRA
Family: QRA Management
What QRA Management contributes to Cardinal Health
QRA Management is responsible for strategic oversight and leadership direction within the QRA function
Qualifications:
What is expected of you and others at this level in Quality & Regulatory Affairs for functional success
Manages professional employees and/or supervisors; may manage business support, technical or production staff
Has accountability for managing financial resources
Provides technical guidance to employees
Develops processes and procedures to implement functional strategies
Has in-depth expertise in own job family and knowledge of the related job families
Applies expertise to improve effectiveness and provide guidance to employees in own area
Makes decisions, often difficult and/or unpopular, that impact the work of subordinates within job family; influences subordinates to support decision by presenting rationale/business case
Role models Cardinal Health's high ethical standards and code of conduct
Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs
Proactively identifies talent internally and externally, including participation in succession planning process for job family
Cascades organizational goals through the function/work area to the individual level and ensures individuals understand how they can contribute
Builds confidence and respect of others through a positive and energizing style
Accepts responsibility for establishing goals and achieving results within own job family, holding self and others accountable for results
Manages budget for own area and allocates resources accordingly, applying knowledge of profit drivers within own area/job family
Interprets internal/external business issues and adapts work priorities in own area
Assists in the definition of strategic plans for own work team/job family or key product(s)/service(s)
Works with customers to anticipate and interpret customer needs and business challenges
Identifies quality and service-oriented customer solutions and shares key learnings with others
Resolves operational problems that impact the effectiveness of own area
Encourages subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work
Works collaboratively with internal/external groups to achieve business results, integrating the diverse perspectives of individuals of different backgrounds; coaches others in the dynamics of effective teamwork
Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view
Accountabilities in this role
Develop, implement and enforce regulatory policies and procedures.
Strong technical writing competency
Previous experience leading and managing regulatory audits and responses (DOH, ASSMCA, DEA, FDA, others)
Previous supervisory experience required
Previous experience in Distribution industry is highly desired
Knowledge in PDMA, DEA, 21 CFR 203/205 related regulations pertaining to Distribution business.
Qualifications
Bachelor's degree required, Science or Engineering degree preferred
