Contract Manufacturing Manager

3 weeks ago

Racine, Wisconsin, United States Merz North America Full time
About Merz North America

Merz North America is a leading medical aesthetics company dedicated to delivering innovative solutions for our customers. We are seeking a highly skilled Contract Manufacturing Manager to join our team.

Key Responsibilities
  • Contract Manufacturer Management: Manage daily interface with contract manufacturers, ensuring compliance with global regulations and guidelines.
  • Approval Activities: Coordinate all approval activities in accordance with global regulations and guidelines.
  • Compliance Monitoring: Monitor for ongoing compliance to established agreements, regulations, and expectations.
  • Supply Chain Management: Work with the supply chain to ensure continuity of supply from contract manufacturers.
Process Transfers and Improvements
  • Product and Process Transfers: Lead product and process transfers to and from contract manufacturers.
  • Technology Evaluation: Evaluate and implement new technologies per Quality System Standards, Quality System Regulations, and company procedures.
  • Process Improvement: Drive process improvement initiatives at contract manufacturers on behalf of the legal manufacturer.
  • Cycle Time Reduction: Monitor and facilitate reduction in product manufacturing cycle times.
Audit Activities
  • Site Audits: Perform audits of contract manufacturer sites to ensure compliance with global regulations.
  • Regulatory Inspections: Participate with federal, state, and local regulatory officials during regulatory inspections at Merz and contract manufacturing facilities.
Quality Processes
  • Approval Activities: Coordinate all approval activities for the legal manufacturer in accordance with global regulations and guidelines.
  • Change Controls: Facilitate and manage inter-company change controls and their associated deliverables.
Root Cause Analysis and Corrective Actions
  • Manufacturing Investigations: Support contract manufacturer's manufacturing and laboratory investigations and implementation of meaningful CAPA.
  • CAPA Approval: Serve as a NCR/CAPA approver as necessary to support contract manufacturer product release.
Requirements
  • Education: BS/BA in Chemistry, Physical Science, or related field. Masters degree preferred.
  • Experience: 5 years pharmaceutical/medical device manufacturing experience. GLP/GMP experience required. Auditing experience and ASQ certification preferred.
Knowledge, Skills, and Abilities
  • cGMP Regulations: Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
  • Lab Equipment: Proficiency with lab equipment, as well as equipment preventative maintenance and method/process troubleshooting.
  • Quality Experience: Quality experience including quality testing, QA/Regulatory, or Validation. Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Management Systems (LIMS), and Quality Management software.
Benefits
  • Comprehensive Benefits: Comprehensive medical, dental, and vision plans.
  • PTO and Holidays: 20 days of paid time off and 15 paid holidays.
  • Paid Sick Leave: Paid sick leave.
  • Paid Parental Leave: Paid parental leave.
  • 401(k): 401(k) plan.
  • Employee Bonuses: Employee bonuses.

Merz North America is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to being a trusted partner focused on our customers while not forgetting about our employees.

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