Description

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 Associate Manager/Manager- Investigations is responsible for providing tactical and strategic leadership for Quality Systems Investigations Including, but not limited to: Non-Conformance and CAPA teams. Day-lo-day activities include management of temporary and regular Quality Resources for the Investigation, Root Cause Analysis, Corrective and Preventive Actions, and Effectiveness associated with Non-Conformances and CAPAs. Responsible for Management of the CAPA and Material Review Boards (CRB/MRB). Subject Matter Expert and Quality System owner for CAPA/NCR; SOP owner and primary audit resource for support of Internal/External Audits. Position will operate as a liaison among the various functions and the Quality department to assure strategic alignment, global harmonization and compliance by supporting the alignment and definition of processes and procedures.

What You Will Do

• CAPA System: Responsible for the oversight of the investigations team. Ensures there is a CAPA program established. Role works with direct management to ensure appropriate processes and training are established to investigate and properly document root cause investigations, including impact assessments, product disposition, timely completion of CA/PA and effectiveness checks. Works with direct management and investigations staff to ensure the progression of investigations are timely and have compliant closures per established KPls. Presentation of investigation findings lo key stakeholders and site senior management. Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste. Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices. Monitor quality metrics to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action when needed.
• Quality initiatives:  Supports new quality improvement initiatives/ projects in accordance with cGMP expectations to improve compliance, quality levels (reducing defects), and improve operational efficiencies. Works with manufacturing and other functional groups on manufacturing regulatory compliance issues. Participate with federal, state, and local regulatory officials during regulatory inspections.
• Adherence to Regulations:  Ensure applicability of current company policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable global, federal, state, and local regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.), State Boards of Pharmacy etc.) that govern Merz activities.
• Participate in inspections and audits: Support continued company certification to the appropriate Quality Management System Standards and Regulations Present CAPA system during inspections and assist with all related audits and inspections as required.
• Personnel Management: Manage staff including Interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Minimum Requirements

• Bachelor's Degree
• 3-5 years Medical Device or Pharmaceutical Manufacturing and/or other regulated industry or similar experience.

Preferred Qualifications

• Bachelor's Degree Physical Science

Technical & Functional Skills

• Excellent written and oral communication skills with attention to detail required.
• Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines required.
• Ability to host, facilitate and execute audits with internal and external audiences required.
• Knowledge and understanding of US and ex-US regulations and ICH guidelines required.
• Highly computer literate (Word, Excel PowerPoint), including formatting and getting documents submission-ready required.
• Lean / Six Sigma Green Belt.
• ASQ CQA, CQE, CQMOE.
• Knowledge of Good Manufacturing Practice and Good Documentation Practice principles.
• CAPA
• RCA
• (x)FMEA
• 21CFR820
• 93/42/EEC
• ISO 13485
• ISO 14971
• Ability to work effectively in a global, matrix environment required.
• Ability to work independently as well as direct and control the efforts of Direct Reports as applicable required.
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts required.

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!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Requirements