Director, Quality Management
Location:
Cary , North Carolina
Posted:
January 12, 2017
Reference:
16010283-en-us

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.


We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.


Join our team of leaders to begin a rewarding career.


 

Director, Quality Management

Position Description

Within Biologics it is the responsibility of all team members to read, understand, and comply with all policies and procedures that apply to each specific role.  It is the obligation of management, managers, supervisors and team leads to ensure quality assurance and compliance with pertinent policies and procedures.  In essence, management, managers, supervisors and team leads “own” the responsibility of quality assurance and compliance.  The Director of Quality Assurance (“DQA”) collaborates to set policy and procedures and then audits/monitors quality assurance. The DQA is principally responsible for the development and implementation of the Company’s quality assurance program through the development and implementation of quality assurance and compliance standards via policies and procedures, training, auditing and monitoring, facilitating internal reporting, compliance-related investigations, and keeping the VP/General Manager informed on quality assurance and compliance matters.  The DQA is responsible for the development and operation of the Company’s privacy program.  Additionally, the DQA will work closely with and collaborate with the VP/General Manager and other senior officers within the Company to provide overall vision, strategy and support of quality assurance initiatives. The focus is on proactive management of quality assurance risks and preventive management as opposed to crisis management.  The ideal candidate is a well-spoken, organized, energetic, enthusiastic and optimistic leader with the ability to work collaboratively with team members, other areas of the Biologics team, patients, providers and clients. The DQA must also be able to work independently and to be able to make tough and difficult reports when necessary.
 
The DQA will have direct access to: All members of the Leadership Team within Company, All business units within the Company, Legal counsel
 
Essential Duties and Responsibilities
 
Team Leadership
  • Exhibit strong leadership skills that effectively motivate employees to provide outstanding customer service
  • Attract, retain, grow and lead a cohesive and effective quality assurance team that is respected by the organization, at all levels, which is vital to the Company’s success.
  • Take a positive, equitable approach to developing employees through training, coaching and mentoring
  • Encourage and promote a collaborative environment to better serve each other
  • Implement initiatives to support smooth operation of the team
  • Responsible for overseeing the training and development activities for the team to meet performance matrix
  • Conduct performance reviews quarterly and facilitate weekly team meetings to provide updates
  • Provide ongoing positive and corrective feedback with the goal to improve overall performance
Quality Assurance Program/System
  • Develop, implement, administer, update and monitor the Company’s quality assurance programs adopted by business units throughout all areas and functions of the Company.
  • Manage the internal audit function and ensure that robust auditing and monitoring systems are in place, monitor compliance, and monitor and address identified risk areas.
  • Ensure all alleged violations of rules, regulations, policies and procedures are responded to quickly and efficiently and that there is a system in place for handling violations.
  • Remain abreast of the status of all quality assurance and compliance activities and to identify trends, assists in the identification of potential areas of vulnerability and risk; develop and/or implement compliance and policies and procedures for the resolutions of all issues and complaints.
  • Ensure that the VP/General Manager is immediately notified of concerns or reports of violations relating to members of senior management, accounting, internal control, auditing, regulatory or financial matters.
  • Collaborate with other members of the Leadership Team, including, but not limited to, risk management, audit, human resources and legal (outside) to direct quality assurance and compliance issues to appropriate channels for investigation and resolution.
  • Responding to government investigations and queries as the principal point of contact.
  • Serve as principal point of contact for all audit inquiries.
  • Promote use of quality assurance hotline, heightened awareness of applicable policies and codes of conduct, and understanding of new and existing compliance issues.
  • Ensure that internal reporting mechanisms are developed, implemented, maintained and actively monitored to enable Company employees to report suggestions or concerns regarding the Company’s quality assurance programs and potential compliance violations.
  • Ensure that all concerns and reports of violations throughout the Company are investigated and resolved.
  • Manages accreditations and continuous compliance with accreditation standards
Quality Operations
  • Implementing written policies, procedures, and standards of conduct
  • Establishing a quality assurance committee
  • Developing effective lines of communication
  • Enforcing standards through well publicized disciplinary guidelines and developing policies addressing dealings with sanctioned individuals
  • Conducting periodic risk assessments and response plans
  • Conducting internal monitoring and auditing
  • Responding promptly on detected offenses, developing corrective action, and reporting findings to the VP/General Manager
  • Understanding of vendor management and vendor processes
 
The DQA and his or her designees have the authority to review all documents and other information that are relevant to quality assurance activities, including, but not limited to, research data, patient records, billing records, and records concerning the marketing efforts of the Company, and all arrangements with other parties, including employees, professionals on staff, independent contractors, suppliers, and agents. This enables the DQA to review contracts and obligations (seeking the advice of legal counsel, where appropriate) that allow the Company to comply with all contracted obligations.  Additionally, the DQA will review any material contracts that may contain referral and payment issues that could violate the anti-kickback statues and any other legal or regulatory requirements.
 
In addition, the DQA will be responsible for all internal audit reports and will work closely with key managers to identify trends inconsistent with policies, procedures and contractual obligations. The DQA should ascertain patterns that require a change in policy and forward these issues to the quality assurance committee to remedy the problem.

Qualifications

Minimum Requirements
10+ years quality assurance or related experience and 7+ years managerial experience

Critical Skills
Bachelor’s degree in Business, Law, Accounting, Pharmacy or other related area

Additional Knowledge & Skills
Demonstrated knowledge and understanding of the required elements of health insurance products

Demonstrated knowledge and understanding of the Anti-kickback Statute, the False Claims Act, and the FDA rules and regulations, Pharmacy and Nurse licensure regulations

Experience modeling business processes using a variety of tools and techniques

Experience in Good Manufacturing Practice & Good Clinical Practice quality a plus

Must be detail-oriented, well-organized self–starter with high energy and creativity and ability to adapt to change in a positive manner

Ability to effectively utilize reference materials

Excellent oral and written communication skills

Education
4-year degree in related field or equivalent experience

Certifications/Licensure
Lean Six Sigma training or certification strongly preferred, green belt level at a minimum

Physical Requirements
General Office Demands

Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.

We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.

But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.

Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

Job Specifics
Grade: 110
Job Family Title: Quality Assurance Manager 5


A little about us:
McKesson is in business for better health.

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