Vice President, National Office of Quality
The VP of Quality provides leadership to the National Office of Quality. The position is accountable for the design and execution of the Quality Management functional strategy. Individual will use their knowledge of both regulations and business needs to help the organization achieve compliance in a manner that supports the goals of the business wherever possible.
Responsibilities include leadership of direct reports and the wider quality team; accountability for budgeting and cost control; accountability for implementation and management of compliance applicable laboratory regulations; audit programs; accountability for maintaining constructive and effective relationships with external regulatory contacts (both clients and national regulatory bodies); maintaining organizational awareness of regulatory developments and requirements and responsibility for ensuring compliance; issues are identified and brought to the attention of the appropriate business managers in a timely manner.
- Develops and implements strategy for achieving and maintaining regulatory compliance within all Labcorp Diagnostic Laboratories.
- Leadership responsibility for the Global Quality Management Systems within the organization; including full range of budgeting, workload and resource assessment, recruitment, performance evaluation, professional and personal training and development, implementation and follow-up of departmental objectives, etc.
- Accountable for Global Quality Budget Control
- Defines and ensures the implementation and operation Global Quality Management System, in line with Regulatory Authority expectations
- Implements an organizational framework for facilitating the continual improvement of the Global Quality Management System in line with changes to regulations and best practice.
- Provide expertise, leadership, consultation/arbitration and independent review to the global Labcorp organization and to Clients on aspects of quality compliance
- Sets global quality objectives for sites/regions and monitors appropriate performance metrics and data trends to facilitate improved compliance and efficiency of quality activities
- Leads global quality related process improvement initiatives
- Approves global quality documents (SOPs, Policies, etc)
- Approves Quality Agreements with Key Clients
- Represents Labcorp quality at conferences and seminars and acts as Labcorp quality Ambassador to key Clients
- Interacts with other external quality organizations and/or regulatory agencies to assure Labcorp is in line with current industry trends
- Labcorp board of directors – VP co-presents with the CMO to the board and works with the CMO to develop the board report for meetings.
- Meetings and discussions about quality concerns and initiatives with all levels of leadership (EVP, SVP, VP, Managers, Legal, etc.)
- Cross functional committees – Chair of several committees, approve committee actions. Examples – Report Improvement Committee, Laboratory Advisory Committee, Laboratory Certification
- Quality Footprint – oversee and approve quarterly NOQ newsletter
- NOQ meetings – Full staff annual conference and directors only annual working meeting
- Regulatory interpretation and implementation
- Science and Technology – Technical bulletins
- All laboratory-related due diligence calls/meetings
- Quality consultation for the Mobile clinic
- CAP – communications with CAP sales and marketing team; decision maker on use of CAP materials for PT and for electronic data reporting process
- CAP – Working with two other Labcorp leaders to develop training for pathologist laboratory directors
- CSLI – review of consensus documents, add users to access documents
- ACLA – committee member, meet with CMS representatives to lobby for regulatory change; attend CLIAC meetings to interact with regulators and other industry leaders
- Quality Consultant for MedTox Diagnostic – review recall information, IFU change review, inspection and complaint letter review, Risk assessment reviews
- Depositions for various lawsuits
- 15 years’ quality experience in clinical laboratory or related industry; at least 2 years in a senior management role
- Experience of industry quality systems/standards, e.g., ISO 15189
- Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
- Proven leadership skills
- Experience leading strategic process improvement initiatives
- Customer service orientated, i.e. ability to interact effectively with clients and regulatory authorities
- Computer literate
- Bachelor’s Degree Medical Technology, Chemistry or Biology related discipline
- Postgraduate degree (MS/MA or equivalent) preferred
- Management qualification/certification, e.g. MBA (may be substituted by significant management experience)
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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