NEUROVUE is disrupting the Life Sciences consulting paradigm with a proprietary approach to talent attraction and retention. With focus and extensive investment, NEUROVUE has created an unparalleled employment experience that attracts industry top minds for our clients' project needs. Through this innovative approach, clients rely upon NEUROVUE for project-based precision and execution.
Our industry demands a firm that continuously develops and provides top talent focused on achieving complex project goals. NEUROVUE is the complete and trusted solution to these specialized talent needs.
NEUROVUE is seeking advanced degree life-sciences professional to serve as a Senior Quality Assurance Manager, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.
Responsibilities:
Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management
Participate and may lead Material Review Board forums
Represent quality team on cross-function meetings and improvement initiatives
Utilizes Good Manufacturing Principles in all areas of responsibility.
Oversees and manages the Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as the Deviation and Change Management systems. This includes ensuring timeliness, compliance, completeness and accuracy of system deliverables.
Supports the use of TrackWise for Change and Deviation Management deliverables
Ensure internal departments maintain the highest quality standards and are aligned with all regulations/procedures by driving continuous improvement activities.
Conduct and manage vendor audits to ensure compliance to all relevant policies and procedures as required
Author vendor audit reports
Perform trend review and metric reporting for vendor non-conformance investigations
Advances quality events (as necessary) to QA Director and works with QA Director to periodically review significant quality aspects of Facilities, Utilities, Maintenance, Engineering, Validation, and Quality Risk Management, as well as Deviation and Change Management.
Quality Sponsor and interacts with clients on quality issues and is an advocate on the company's quality concept.
Implements and monitors key performance indicators within area of responsibility.
Provides supervision of direct reports in support of their activities.
Experience
Minimum of 5-8 years of experience in the Pharmaceutical or highly regulated industry and at least 3-5 years of direct supervisory experience required.
Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others), people management required.
Experience with QA procedures in a pharmaceutical, or highly regulated environment with emphasis on documentation.