Global Quality Operations Manager Mfg Transfer

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

The Global Quality Operations Manager, Manufacturing Transfer is responsible for ensuring the successful quality oversight, governance, and execution of manufacturing transfer activities across internal sites and external manufacturing partners. This role provides Quality leadership and Subject Matter Expertise (SME) for technology transfers, including product, process, equipment, analytical methods, and facility readiness. The position partners cross-functionally with Manufacturing, MS&T, Supply Chain, Engineering, R&D, and Regulatory Affairs to ensure compliant, efficient, and robust transfer of products across the lifecycle. The role ensures that all transfer-related activities meet applicable global regulatory requirements, quality standards, and business objectives while supporting continuous improvement and operational excellence. The role will require significant on-site presence of the site product(s) will be transferred to.

What You Will Do

• Manufacturing Transfer Quality Leadership Serve as the Global Quality lead for manufacturing transfer programs across sites and Contract Manufacturing Organizations (CMOs). Provide Quality oversight for: - Technology transfer processes (process, analytical, and packaging) - Facility, equipment, and utility readiness - Process validation, verification, and continued process performance Ensure appropriate implementation of validation strategies (IQ/OQ/PQ, PPQ, revalidation) during transfers.
• Quality System & Compliance Oversight Ensure all transfer activities comply with: - ISO 13485, 21 CFR Part 820, cGMP - EU MDR and other applicable global regulations Provide Quality input and approval for transfer documentation including: - Transfer plans - Risk assessments (FMEA) - Validation protocols/reports - Comparability assessments Interface with regulatory agencies and notified bodies as required.
• Cross-functional Program Execution Partner with Quality, MS&T, Operations, PMO, Engineering, and Supply Chain to: Define transfer strategy, timelines, and deliverables Identify and mitigate risks impacting product quality or compliance Ensure alignment of design controls and process validation execution Act as the Quality liaison across global teams to ensure alignment and execution of program milestones.
• Quality Risk Management & Problem Resolution Lead and/or support quality risk assessments associated with manufacturing transfer activities. Ensure appropriate investigation, root cause analysis, and CAPA implementation for transfer-related issues. Monitor trends and proactively address risks to ensure successful transfer outcomes.
• Quality Metrics & Continuous Improvement Define and monitor key quality metrics related to transfer performance (e.g., right-first-time, validation success rates, deviation trends). Drive continuous improvement initiatives to enhance: - Transfer efficiency - Process robustness - Quality system effectiveness Identify opportunities to standardize transfer processes and best practices globally.
• Documentation & QMS Integration Ensure proper documentation of all processes required for transfer activities within the QMS. Support development and maintenance of global procedures and standards for manufacturing transfer. Ensure knowledge transfer and training across sites and functions.
• Inspection & Audit Readiness Support internal and external audits related to manufacturing transfer activities. Represent Quality during regulatory inspections and partner audits as required. Ensure inspection readiness for all transfer-related documentation and processes.
• Organizational & Strategic Support Provide strategic input to Global Quality and Tech Ops leadership on: - Transfer prioritization and risks - Capacity readiness across network - Quality strategy for lifecycle management Participate in management reviews and escalate critical quality issues as needed.
• Overall Leadership responsibilities Approve manufacturing transfer quality deliverables (protocols, reports, risk assessments) Escalate critical quality risks impacting product supply or compliance Support or act as delegate for Quality leadership as needed Approve readiness for validation and product launch related to transfers

Minimum Requirements

• Bachelor of Science (B.S.) in a Physical Science or equivalent
• 7+ years in the Medical products Industry
• 5+ years in a Quality function, including experience in managing and supervising teams.

Preferred Qualifications

• Master's Degree in a Physical Science or equivalent
• ASQ certifications such as CQA, CQE, CQMOE are highly desired.
• Lean/Six Sigma Green Belt.

Technical & Functional Skills

• Strong written and oral communication skills with attention to detail.
• Excellent organizational skills and the ability to prioritize tasks while adhering to timelines.
• Proficient in hosting and facilitating audits with both internal and external audiences.
• Knowledge of US and international regulations, including ICH guidelines.
• Highly skilled in Microsoft Office applications (Word, Excel, PowerPoint) as well as Copilot, particularly for document preparation and submission.
• Ability to work effectively in a global, matrixed environment.
• Capable of working independently while managing and directing the efforts of indirect team members
• Strong interpersonal skills with the ability to collaborate effectively with technical experts across various departments.