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Manager, Clinical Quality Assurance – Remote or Hybrid

Baim Institute for Clinical Research

This is a Contract position in Las Vegas, NV posted October 19, 2022.

The Manager of Clinical Quality Assurance has overall responsibility for the corporate quality program.

This includes overseeing all corporate quality systems including the ZenQMS Dashboard (Zen) or any other quality systems, the Corrective Action/ Preventative Action (CAPA) system and SOP system.

The Manager of Clinical Quality Assurance is responsible for hosting sponsor audits as well as regulatory inspections.

The Manager will conduct audits of vendors and in addition to conducting internal audits of processes, departments and systems.

The Manager is also responsible leading quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs and applicable regulations.

This individual will need to travel to the Baim office on occasion for certain functions, regulatory inspections in particular.

Primary Duties: 1.

Manage and maintain the ZenQMS Dashboard (Zen) to ensure formal documentation of corporate training.

ZEN is the module that provides training of all professional staff on Standard Operating Procedures (SOPs), Guidelines, courses and other training initiatives.

Interface with other departments to establish and resolve Quality Assurance training needs as well as train staff.

2.

Management of the Standard Operating Procedures (SOPs) database.

Assure that new or revised SOPs and Guidelines are formatted and referenced consistently prior to placing them into the review queue.

3.

Manage the operational support for the Quality Event Portal, covering Quality Events and CAPA’s (Corrective and Preventative Action) as well as other Quality Assurance Action Items to closure.

4.

Responsible for participating in Quality Assurance Reports for any Senior Management meetings, Annual, and Ad-Hoc reports.

i.e., Training Compliance Numbers, Aging Reports, open CAPAs, Events, and audit findings.

5.

Review and approve key deliverables and validation artifacts including but not limited to computer system validation documentation, study build documentation and change control documents.

6.

Perform and conduct internal audits, external vendor audits, and FDA regulatory Inspections, including preparing and writing relevant audit reports, as needed.

7.

Organize materials, Training presentations, collect/complete required documentation, etc.

8.

Create QA Project Plans and various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs and applicable regulations.

9.

Development of and adherence to annual QA budget 10.

Keep abreast of changing regulatory requirements Requirements: Education: Required: Bachelor’s degree Preferred: Master’s degree Yrs.

of related experience: Required: 5 years Preferred: 2 in QA Auditing Working Relationships: The Clinical QA Manager will interact with all staff, including senior and middle management across the organization as well as various Sponsor representatives, FDA, etc.

Complexity: The Clinical QA Manager will work with Department Heads to support the functional operation and administration of the Quality Program and other associated quality initiatives.

The ability to understand complex regulations and assist in the determination of their impact on the organization is key.

Additionally, have the ability to work closely with multiple departmental areas and coordinate company-wide initiatives is also a plus.

Training Experience with ICH Good Clinical Practice guideline requirements and FDA regulations (21 CFR Part 11, 50, 54, 56, 312, 314, 812, etc.).

Additionally, becoming familiar with new regulations/guidelines associated with clinical research (including auditing, quality assurance issues, etc.