Team Leader, QA Investigations

Merz Aesthetics; Lonay; Hybrid; CHF 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Flexible working hours & home office

Generous annual leave

Training programs

Premium accident insurance

Pension fund

Discount programs

Employee Assistance Program

Team activities

Sustainable development initiatives

Zusammenfassung

Merz Aesthetics in Lonay, Switzerland, seeks a Team Leader for QA Investigations to lead NCRs, CAPAs, and issue reviews within a regulated Life Sciences environment.

You will drive root cause analyses and risk-based investigations with cross-functional teams, ensuring timely closure and robust QMS documentation.

Qualifikationen

• Bachelor's Degree in Life Sciences, Pharmacy, Medical Device, Engineering, or related scientific discipline, or a Master's Degree in Life Sciences, Medical Device, Engineering, or related scientific discipline.
• 12+ years of experience in a regulated Life Sciences environment, with significant experience in the Medical Device, Combination Products, or Pharmaceutical industries.
• Hands-on experience in Manufacturing Operations, Quality Operations, Production Support, Process Engineering, or related operational functions.
• Demonstrated expertise in NCR, CAPA, Issue Review, Root Cause Analysis, and Quality System investigations, including leading complex cross-functional investigations with Manufacturing, Engineering, Quality Control, Validation, and Supply Chain stakeholders.
• Significant people management experience.

Aufgaben

• Lead and execute NCRs, Issue Reviews, CAPAs, and quality investigations in compliance with Quality System and regulatory requirements.
• Provide day-to-day leadership to the QA Investigations team, coordinating priorities, monitoring progress, and coaching team members.
• Apply robust root cause analysis and risk-based methodologies, ensure timely record closure, and support effective CAPA implementation.
• Monitor performance indicators, maintain audit and inspection readiness, improve investigation processes, and manage Quality System documentation.
• Partner with cross-functional stakeholders and responsibly leverage AI and digital tools to enhance decision-making and operational effectiveness.

Kenntnisse

GMP compliance

Risk management

Investigation methods

eQMS proficiency

Power BI

Leadership

Project management

Communication

Stakeholder management

English fluent

Ausbildung

Bachelor's in Life Sciences

Master's in Life Sciences/Engineering

Tools

eQMS

Excel

Word

Jobbeschreibung

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

Position Snapshot

Job Title: Team Leader, QA Investigations

Location: Lonay (Vaud, Switzerland)

Activity rate: 100%

Type of contract: CDI

Key Responsibilities

Lead and execute NCRs, Issue Reviews, CAPAs, and quality investigations in compliance with Quality System and regulatory requirements.

Provide day-to-day leadership to the QA Investigations team, coordinating priorities, monitoring progress, and coaching team members.

Apply robust root cause analysis and risk-based methodologies, ensure timely record closure, and support effective CAPA implementation.

Monitor performance indicators, maintain audit and inspection readiness, improve investigation processes, and manage Quality System documentation.

Partner with cross-functional stakeholders and responsibly leverage AI and digital tools to enhance decision-making and operational effectiveness.

What Will Make You Successful

Knowledge & Skills:

• GMP and cGMP requirements.
• ISO 13485, EU MDR 2017/745, and FDA Quality System Regulations.
• Risk Management principles.
• Investigation methodologies, including 5 Why, Fishbone, 8D, and FMEA.
• Audit and inspection practices.
• Proficiency with electronic Quality Management Systems (eQMS).
• Proficiency in Microsoft Office, including Excel, Word, Teams, and Power BI.
• Knowledge and practical application of Artificial Intelligence (AI) and digital tools.
• Strong people leadership, coaching, talent development, and accountability skills.
• Excellent organizational, prioritization, project management, and time management abilities.
• Pragmatic problem-solving mindset, resiliency, and high level of ownership.
• Strong collaboration, stakeholder management, and influencing skills, with the ability to challenge constructively.
• Excellent written and verbal communication skills.
• Emotional intelligence and the ability to motivate and influence others.
• Fluent English, written and spoken.

Education & Qualifications

Bachelor's Degree in Life Sciences, Pharmacy, Medical Device, Engineering, or a related scientific discipline, or a Master's Degree in Life Sciences, Medical Device, Engineering, or a related scientific discipline.

Professional Experience

12+ years of experience in a regulated Life Sciences environment, with significant experience in the Medical Device, Combination Products, or Pharmaceutical industries. Strong hands-on experience in Manufacturing Operations, Quality Operations, Production Support, Process Engineering, or related operational functions.

Demonstrated expertise in NCR, CAPA, Issue Review, Root Cause Analysis, and Quality System investigations, including leading complex cross-functional investigations with Manufacturing, Engineering, Quality Control, Validation, and Supply Chain stakeholders.

Significant people management experience.

What We Offer

Work-life balance: Our time is precious; to promote a good work-life integration, we allow flexible working hours and home office work, depending on the position requirements. Our employees also benefit from generous annual leave arrangements.

Ongoing training: Your personal and professional development is key to our success. You will have access to multiple training programs (e.g., LinkedIn Learning, FranklinCovey, Harvard online) and development opportunities.

Benefits: We offer various benefits, such as premium accident insurance, attractive Pension Fund, discounts programs, Employee Assistance Program, and regular fun team activities.

Sustainable development: The Merz Group is investing at every site to achieve carbon neutrality by 2035.