- Plans, coordinates, and directs quality assurance programs proactively and helps establish standards designed to ensure continuous data quality.
- Reviews and evaluates inputs related to the Quality Management System for compliance, trends, effectiveness and conformance to industry standards as well as applicable internal and regulatory requirements.
- Review processes and systems on an ongoing basis to determine where improvements can be made; works with site leadership to revise / establish procedures, standards, and systems.
- Directly supervise the site Quality Team including the selection and development of people, resources, and budgets necessary to perform the functions of the department; trains workforce as required in various quality methods, standards, and procedures.
- Conduct announced and unannounced audits for pre-clinical studies (in vitro and in vivo) to ensure operations are on the highest quality level as well as lead the site internal audit program.
- Perform review and data verification of reports for pre-clinical studies, including Study Protocols, study reports, and ancillary records.
- Lead SOP management/review cycles along with associated training.
- Ensure training program in place for staff training on procedures introduced by new and revised SOPs.
- Prepare site deviation, CAPA, and change management documentation.
- Supporting monitoring for care and use of animals to ensure activities are conducted in accordance with the principles outlined in the Guide for the Care and Use of Laboratory Animals, 8th Edition, 2011 (National Research Council) and in compliance with approved IACUC protocols
- BS/BSc degree (MS or greater preferred) in relevant scientific field
- 7+ years of progressive quality assurance background in the pharmaceutical, biotech or preclinical industry is preferred.
- At least 3+ years prior experience managing and executing internal site audit programs.
- Strong problem solving and decision-making abilities with focus on continuous improvement.
- Self-motivated leader with a strategic mindset.
- Direct experience managing an eQMS system (ZenQMS experience preferred).
- Well-developed organizational skills with the ability to manage a variety of tasks with competing priorities.
- Working knowledge of KPI's, GxP/ISO requirements, Six Sigma and Lean principles.
- Excellent verbal and written communication skills including ability to present.
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Quality Assurance Manager - Hershey, United States - Clinical Dynamix
Description
Position Summary:
The Quality Assurance Manager is an onsite mid-senior level position based out of Hershey, Pennsylvania and is responsible for ensuring that the company's products and services meet the highest quality standards and applicable regulations.
This position will be responsible for assessing, developing, implementing, and assuring compliance with local and global quality standards.The manager will lead a continuous improvement program to proactively identify and resolve compliance risks in conjunction with site and global leadership.
They will lead a team of quality assurance professionals ensuring successful management of annual quality objectives as well as monitoring workload to confirm they have the appropriate level of support and development to perform their assigned job responsibilities.
Main Responsibilities:
Key Qualifications:
