Contract Manufacturing Quality Manager (Architecture)
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 industry standards of manufacturing and manufacturing quality controls. Required
- Ability to make data driven decisions around manufacturing quality metrics. Preferred
- Quality experience including quality testing, QA/Regulatory, or Validation. Experience with FDA, European agency regulations, cGMP regulations and Quality Management software. Preferred
- ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent. Preferred
- Ability to work with company staff and communicate effectively throughout the organization is essential. Preferred
- Excellent written and oral communication skills. Preferred
Benefits:
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more!
Your benefits and PTO start the date you're hired with no waiting period!
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Quality
