Director - Quality Assurance - Biologics - Raleigh-Durham

Job 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 CEO and the Board of Directors informed on quality assurance and compliance matters.


The DQA must attract, retain, grow and lead a cohesive and effective quality assurance team that is respected by the organization, at all levels, from the business units to the Board, which is vital to the Company’s success.
Essential Duties and Responsibilities

The DQA principal duties:
- 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.
- Manage and provide oversight for regulatory compliance, ethics programs, HIPAA and privacy matters.
- 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 CEO and Board Chair are 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

Desired Skills and Experience
Bachelor’s degree in Business, Law, Accounting, Pharmacy or other related area.
Demonstrated five years work experience in quality assurance, policy and compliance related matters.
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.
A minimum of five years management experience.
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
Working knowledge of computers and excellent word processing skills

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