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Careers that Change Lives


A Day in the Life

GLP Compliance / Audit Manager

 

Careers That Change Lives

 

In this role supporting the Surgical Innovations group, you will ensure that independent study phase audits for support of GLP studies are performed.

 

 

A Day in the Life

 

§  You will perform the coordination and/or preparation of internal and external audits and compliance in accordance with Good Laboratory Practice (GLP) regulatory standards (including FDA and its equivalents outside the US as well as other government regulatory agencies/authorities)

§  You will interpret GLP government regulations as they apply to processes, practices and procedures

§  You will implement policies and procedures to ensure that these are in compliance with the appropriate GLP statutes and regulations and ensure that regulatory reporting requirements are met

§  You will investigate and resolve compliance problems, questions or complaints received from other units of the organization, government regulatory agencies, etc.

§  You will analyze audit data and present findings to management, support Corrective Action Plans and provide coaching to business partners

§  You will develop and implement programs designed to increase employee awareness and knowledge of GLP compliance policies

§  You will maintain a thorough working knowledge and ensure compliance (audits) to the regulatory requirements and industry practices at the North Haven Surgical Research Laboratory:      

o   21 CFR part 11 Electronic Records Regulations

o   21 CFR part 58 Good Laboratory Practices Regulations

o   ISO Standards

 

Must Have: Minimum Requirements

 

You will have a Bachelors degree in a scientific discipline and 5+ years’ experience or an advanced degree and 3+ years’ experience in quality assurance in a GLP regulated environment.

 

Nice to Have

 

§  Management experience

§  Prior experience working in a GLP regulated research lab environment

§  Strong working knowledge of quality assurance processes and procedures specifically as they relate to GLP. 

§  Quality assurance experience working in a pharmaceutical or biotech environment with the FDA or other regulatory agency experience

 



About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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