Director Of Quality Assurance

Seven Life Sciences are looking for a Director of Quality Assurance to work in Monmouth Junction, New Jersey.

This is a hybrid role offering a salary of $140k – $150k Per Annum.

Key Responsibilities:

• Develop and implement a quality strategic plan for the Quality Management System (QMS) to successfully support lab developed tests (LDT) and FDA-approved IVD medical devices including software algorithms intended to provide patient information and support.

• Provide leadership and mentorship for QA team and function cross-functionally, while ensuring QMS areas are adequately supported and resourced.

• Partner with the lab director(s), mangers, supervisors and other stakeholders to develop and implement policies and procedures and train lab staff on them.

• Maintain company compliance to CAP/CLIA regulations/standards for LDT, NYSDOH and other state regulations and 21 CFR 820 when applicable.

• First lead the creation of a new Quality Plan, and then collaborate with the Clinical Laboratory Director, Director of Operations and Quality Team to optimize and enforce the Quality Plan as it is written.

Requirements

• BSc, MSc, or PhD in Life Science, Medical Technology, Chemistry or Engineering.

• NYS CLT License (preferred).

• At least 10 years of experience in Quality Assurance implementing and/or maintaining quality management systems in a regulated clinical laboratory or an IVD company.

• 5+ years of experience in a lab providing services to pharma and biotech companies in clinical trials.

• Demonstrated knowledge of all laws and regulations that are required by CLIA, CAP, OSHA and other related legislative and/or state health departments and organizations.

Working with Seven Life Science:

We have been helping professionals find exciting new roles for almost a decade, so we know exactly where to look when it comes to sourcing the best opportunities. We operate across the UK, and, with over 300 five-star reviews, multiple awards and amazing relationships with the biggest employers in UK Life Science, we give you the best chance of landing your next role.

If you believe you have the experience above, the desire to participate in creating a new solution-set within the genomic sequencing space, one that marries the best from standards of care and biopharma, then, we are waiting to speak with you

We have a reputation for recruiting at lightning speed, however, we can only respond to candidates who meet the exact requirements of the position. If you have any queries about a role or application, please visit our website where our amazing candidate support team will be more than happy to help.