Manager, Quality Assurance

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* This role is onsite in Raleigh office 3 days a week and 2 remote

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* Who We Are: Harvesting Hope with a Growing Family At Merz Therapeutics, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action.

We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference.

As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve.

We pride ourselves on building an inclusive culture where there is room to celebrate individual growth and the ability to contribute to a common good as a collaborative team.

Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.

If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU! #IAmMerzTx Merz Therapeutics is seeking a Manager, Quality Assurance.

This role will be the local Quality Management System representative and be responsible for development and oversight of Supplier Management Program.

The role will be the Liaison to global Quality functions and will focus on compliance of operations with quality related requirements set by authorities and Merz-internal.Essential Duties and ResponsibilitiesLocal Quality Assurance


* Contributing to the development and operations of the Quality Management System requirements for Merz Therapeutics U.S.

within Global therapeutics Quality Management System


* Responsible for contributing to local Quality Management Reviews and writing the Annual Quality Management Report


* Working with regulatory officials during local quality inspections and supporting all Merz sites globally with any requests for information from an authority inspection


* Local lead for Merz Therapeutics U.S.

and Canadian recall activities (process, communication, reporting)


* Managing contracts and budget with local quality vendors


* Lead local contact for internal corporate audits and authority inspections


* Overseeing Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring performance and maintaining the audit schedule


* Monitoring, tracking and investigating deviations


* Corrective and Preventive Action (CAPA) activity implementation, reporting, and close out


* Building a company culture of quality through training, quality initiatives


* Driving quality improvement activities


* Creating, revising, maintaining Quality Assurance Agreements


* Creating work processes for local QA and writing corresponding SOPs.


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