Sr. Manager, Quality Engineering

Company:	Covance Company Profile \| Current Opportunities (1)
Job Location(s):	Dallas
Employment Term:	Regular
Employment Type	Full Time
Start Date:	As soon as possible
Starting Salary Range:	Not Provided
Required Experience:	Open
Related Categories:	Quality Assurance/Safety

Position Description

Business Title	Sr. Manager, Quality Engineering
Requisition ID	21620BR
Job Category	Quality
Locations	USA - Dallas, TX USA - Nationwide
Shift	1
Job Posting	Covance is a leading supplier of drug development services to the biotechnology and pharmaceutical industries. We partner with innovative companies, offering valuable services in all phases of the drug development process as well as analytical and commercial impact services. As an integral part of these partnerships, our employees make a difference in the lives of millions. Before drugs, chemicals, or foods can be sold, they must be evaluated for safety and effectiveness. Covance provides international testing services to clients in the pharmaceutical, food, biotechnology and chemical services industries. Quality Assurance in Covance’s Phase I Clinical Development Services Business is growing! We are looking for individuals with GCP auditing experience. Sr. Manager, Quality Engineering, will support Senior Management, globally, in maintaining robust quality systems within Clinical Pharmacology (CPS) and Early Clinical Development (ECD) through timely and accurate reporting of quality indicators, and assessment of trends. The individual in this role will create and manage the metrology (quality and performance) programs for the Quality Assurance & Regulatory Compliance department, as well as analyze the performance of quality systems and report to management regarding compliance with regulatory requirements. They will also coordinate new quality initiatives and monitor progress of those initiatives. Additional duties and responsibilities include: Embraces Quality Assurance practice of Continuous Improvement and Total Customer Satisfaction. Drives constant improvement of the practices within Clinical Pharmacology Services and Early Clinical Development operations, as well as Quality Assurance to improve efficiency and the effectiveness. Develops and manages the CAPA program, to ensure timely and accurate reporting of quality issues and resolution. Generates periodic reports to management of Key Quality Indicators (KQI), significant issues, and quality trends. Works with Clinical Pharmacology (CPS) and Early Clinical Development (ECD) management teams to achieve and maintain compliance with the Covance Quality Management Systems (CQMS) standards. Track and report metrics for the Quality Dashboard, and the Regulatory Leadership Team. Lead management in tracking issue resolution and reducing roadblocks. Provides expertise by writing and/or reviewing Operational and Quality Assurance SOPs. Provide QA compliance training to new and current employees. Performs general supervisory duties including full range of recruitment and performance evaluation activities, schedules work, prepares training plans, and executes Affirmative Action goals in the department. Meets with clients as necessary to establish/clarify specific compliance requirements and determine appropriate prevention or resolution of client issues. Mentors staff members. Identifies and develops candidates for succession planning. Performs other related duties as assigned by Director QA.
Education/Qualifications	Required: BS/BA degree in science or equivalent professional experience. Advanced degree preferred. Working knowledge and ability to interpret GCPs and other relevant regulatory standards (HIPAA, GMP, etc) as well as a demonstrated mastery of general principles of quality management. Certified Quality Engineer (CQE) or equivalent attainment preferred. Ability to effectively interact with internal and external clients and regulatory personnel, and conduct effective training sessions. Requires strong customer service skills. Ability to negotiate issues, ideas and suggestions. Skilled in concise writing.
Experience	Required: Requires a minimum of seven (7) years of relevant experience. Requires a minimum of three (3) years of Clinical Quality Assurance/Engineering leadership experience. Additional experience may be substituted for education requirements.
Days per week	5