Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Director of Quality Assurance
Madison, WI. Biotech industry.
Direct Hire. 170-200k
Talentry is looking for a Director of Quality Assurance to
help in implementing a QMS system, set up SOPs, and lead the communication with
vendors, partners, CROs, etc. The right person for this role will have experience
with auditing, and will understand what to look for in a good quality system
(Qualio, Zen QMS, etc.)
This position will provide quality oversight to ensure that
cGMP, GLP, and other regulations and policies are followed. He or she will
develop and deliver training materials, SOPs, Risk Assessments, etc. This role works
heavily cross-functionally, both internally and externally.
The Quality Assurance Director will help ensure the highest
level of quality for our products.
BS and 5 years of experience in the pharmaceutical industry
Proven experience with QMS implementation and configuration
3 years of experience in a biotech or pharmaceutical
environment
Solid communication and documentation experience
Proficiency in MS Office products, PM tools, etc.