BSV Associate Manager - Full-time / Part-time

The Healthcare Quality Assurance (QA) Manager is responsible for ensuring compliance with the regulatory requirements of the applicable national regulatory authority and to ensure uniform interpretation and implementation of the Healthcare Quality System across geographically distributed operations. He/She manages communications with internal groups (e.g. Business Development [BD], Operations, etc.), clients, and various federal and local agencies and maintaining procedures and documents to ensure compliance to the applicable regulatory requirements. The Healthcare QA Manager minimizes risks associated with transporting healthcare products, manages internal, client, and agency audits, and ensures that the validation of facilities, systems and supporting equipment are completed as applicable. This position manages supervisors.

Job Duties

Manages and Maintains Internal, Client, and Agency Communications

Manages and conducts internal group (e.g., Operations, BD, Information Technology, etc.) consultations and manages investigations and problem solving regarding healthcare issues to ensure healthcare compliance with rules and regulations. Manages and conducts reviews of policies, procedures, regulations, and specific work instructions with clients to determine specialized requirements and to ensure compliance. Interfaces with client QA departments and attends sales presentations and business reviews to coordinate client activities. Interacts with regulatory agencies to interpret rules and regulations, determine licensure requirements, and submit required reports and correspondence, Conducts follow-ups with agencies after inspections and discovery of internal issues to meet respective agency requirements.

Manages and Maintains Quality Documents and Procedures

Writes and revises standard operating procedures (SOPs) to incorporate agency regulations and ensure proper procedures are followed by Operations personnel. Manages and performs the writing and revision of work instructions to ensure operating procedures and regulations are adhered to across geographic locations. Manages and implements training programs and materials to train QA and internal clients on SOPs, work instructions, and regulatory topics. Interfaces with Corporate Compliance to ensure no overlaps and gaps in procedures and guidelines exist. Evaluates procedures across locations to ensure consistency in content and implementation. Oversees the setup, training, and rollout of the ColdStream CCM application that supports the UPS Temperature True product. Manages and oversees vendor qualification procedures to ensure all potential third party providers that are used as part of the Supply Chain Solutions (SCS) and UPS Temperature True product meet predetermined service criteria. Manages and oversees the ongoing review of qualified vendors to ensure they remain qualified and re-certified as a qualified vendor at the appropriate intervals.

Manages and Develops Others

Manages resources and people processes (e.g., Quality Performance Review [QPR], Career Development, Training, Staffing, etc.) to ensure the day to day administration of processes and formal procedures. Identifies individual and team skill gaps and developmental opportunities (e.g., training, special assignments, conferences, projects, etc.) to facilitate individual and team development. Ensures that direct and indirect reports have documented career goals and detailed plans for achieving these goals to develop them personally and professionally. Conducts frequent performance evaluations in a consistent, fair, and objective manner to facilitate open communication and encourage continuous performance improvement. Holds others accountable to established performance levels to achieve individual and group goals. Resolves individual and group performance issues in accordance with UPS’s policies and procedures in a timely manner to motivate and foster teamwork. Coaches others and provides on-going feedback and support to improve performance. Identifies opportunities to involve others in new and challenging work assignments and/or rotations that advance the skills and capabilities of individuals and the organization. Makes salary recommendations to reward employee performance.

Assesses and Manages Risk

Ensures client product types and service requirements (e.g., storage, etc.) are identified to determine applicable regulations. Manages and conducts assessments of current Supply Chain Solutions (SCS) and UPS Temperature True product capabilities to determine SCS's ability to meet client requirements and proposed solutions. Consults with Corporate Legal to determine compliance implications of pending business opportunities.
Interacts with Contracts, BD, and Solutions to consult on potential business opportunities and possible compliance issues and risks.

Manages and Conducts Audits and Validation

Manages and performs the gathering of information, scheduling, and preparation and distribution of reports to prepare for internal and client audits. Manages and performs internal audits, internal audit interaction, and recording of information and observations to track and trend audit findings, take corrective and preventative action, and maintain proof of audits and documentation. Hosts and manages Corporate Compliance and agency audits to identify and conduct follow-up activities. Manages and performs gap analyses and documents results to determine and implement corrective actions for deviations. Implements and manages change control procedures, training, and audits and participates in writing and revising procedures identified through the validation process to ensure validation is maintained. Manages and oversees the temperature profiling studies of UPS Temperature True product transit lanes to ensure data is collected and interpreted in accordance with predetermined user specifications and written protocols. Manages, oversees, and performs validation activities related to the qualification of temperature controlled transportation equipment (such as refer trailers and passive and active cargo containers), which includes the development of validation master plans, IQ/OQ/PQ protocols and the execution of these

Competencies

Applies Legal, Regulatory, and Safety, Applies Supply Chain and Logistics Knowledge. Assesses and Manages Risk. Conducts Research, Investigate Incidents & Writes Technical Documents.