The Global Systems & Standards Senior communicates the quality policy and objectives to help ensure the maintenance of the overall healthcare compliance for the operation/department. The employee will advise on development of standard operating procedures (SOPs), reviews and approves client and facility work instructions, trains QA personnel and internal clients on SOPs and regulatory topics, and oversees the maintenance of the quality documents. This position participates in internal, client, and agency audits, and follows up on audit outcomes. The HC Quality Assurance Supervisor maintains knowledge of healthcare quality and regulatory requirements: and assesses and addresses risks associated with transporting healthcare and food products.
Responsibilities:
Monitors and instructs for compliance to UPS SCS site license requirements (DEL, MDEL, CDS, PCR).
Promotes Issue resolution, risk management, continuous improvements and project initiatives.
Facilitates, hosts, and respond to audits (Internal, Regulatory Agencies and Clients)
Assists with creation, revision, and approval of Controlled Documents (SOP/WI/Forms).
Provides investigation and Non-conformance reporting, including development of proactive strategies for preventing recurrence.
Changes control management.
Provides Quality and Regulatory compliance guidance to clients and internal staff.
Supports growth of new and expanded facilities, clients and services.
Participates in environmental control and CDS security emergency response action team.
Performs direct reports responsibilities (risk assessment, task delegation, performance evaluation, skills development, constructive feedback, formal performance review, formal career development)
Qualifications:
Bachelor’s degree or International equivalent in Sciences- Required
Pharmaceutical, healthcare or food industry experience - Preferred
Quality Assurance experience - Preferred
QPIC/AQPIC designation - Preferred