Contract Manufacturing Quality Manager

About the business:  Merz is a family-owned medical device and pharmaceutical company headquartered in Germany.

Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.

Key Responsibilities: 

Contract Manufacturer Management:


* Manage daily interface with contract manufacturer(s) that manufacture for and supply finished medical devices and pharmaceutical product to Merz.


* Coordinate changes amongst multiple vendors.


* Monitor for ongoing compliance to established agreements, regulations and expectations.

Activities include regular review of manufacturing processes (i.e.

batch record review, deviation approval, on-site audits etc.


* Work with supply chain to ensure continuity of Supply from CMO.


* Monitor output and quality of output of CMOs

Process transfers and improvements:


* Lead product and process transfers to and from CMO.


* Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and other company procedures.


* Drive process improvement initiatives at CMO on behalf of legal manufacturer.


* Monitor and facilitate reduction in product manufacturing cycle time and increases in capacity at suppliers.

Audit Activities:


* Perform audits of the CMO sites to ensure compliance to global regulations.


* Participate with federal, state, and local regulatory officials during regulatory inspections both at Merz and at Contract Manufacturing facilities.

Quality Processes:


* Coordinate all approval activities for the legal manufacturer in accordance with global regulations and guidelines.


* Facilitate and Manage inter-company change controls and their associated deliverables.

Root Cause Analysis and Corrective Actions:


* Support Contract Manufacturer’s investigations and implementation of meaningful CAPA/SCARs (corrective and preventive actions).


* Serve as NCR/SCAR/CAPA approver as necessary to support CMO production releases.

Design Transfer Support:


* Support organization in the design transfer and implementation of new designs into manufacturing within design control and quality requirements

Education:


* BS/BA in Engineering or related field Required


* Masters degree.

Preferred

Experience: 


* 5 years Pharmaceutical/ Medical Device Manufacturing Quality.

Required


* GMP experience.

Required


* 3 years of experience working with EMS Contract Manufacturing Organization.

Preferred


* Auditing experience, ASQ certification.

Preferred

Knowledge, Skills and Abilities: 


* Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.

Required


* Ability to review testing protocols and reports, operating documents and procedures.  Required


* Ability to work with little or no supervision, and make effective decisions.  Required


* Expertise in i...