Clinical Quality Specialist / Auditor (m/w/d) - befristet auf 2 Jahre

MSD Deutschland; Bubenheim; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

30 days leave

Solid Pension Plan

Bonus plan

Hybrid working model

Job summary

MSD Deutschland's R&D Quality Assurance team in Schwabenheim is seeking a Clinical Quality Specialist / Auditor (m/w/d) on a fixed-term basis to uphold GLP, GCP, and GMP and to review clinical study documentation in a GxP environment.

The role involves conducting internal and external audits, supporting qualification activities, managing risk, and improving the quality system while collaborating with international teams.

Qualifications

• Master’s degree in Life Sciences or related field.
• First years of experience in regulated GxP and QA auditing.
• Proven QA experience in pharma, especially GCP and GMP.
• In-depth regulatory knowledge for veterinary medicinal product development.
• Risk management expertise with mitigation strategies.
• Strong collaboration across cross-functional teams and stakeholders.
• Proficient with document management and QA software; good English/German communication.

Responsibilities

• Review veterinary clinical studies to ensure regulatory compliance.
• Conduct internal and external audits per GxP to assess compliance.
• Support qualification activities and review documentation accuracy.
• Apply risk management to identify and mitigate process risks.
• Maintain and improve the GxP quality system including SOPs and training.
• Collaborate across teams with strong communication and intercultural collaboration.
• Plan and manage tasks independently with good self-organisation.

Skills

Quality assurance

Regulatory knowledge

Risk management

Interpersonal communication

German & English proficiency

Education

Master’s degree in Life Sciences

Job description

Did you always want to work in a company where your work can have a real impact? Are you quality minded and interested making quality consciously a part of your work? Do you enjoy working in an international environment with lots of room for personal development? Do you like working with different departments within a professional organization? Do you enjoy being part of a team and like to use your knowledge for quality systems such as Good Laboratory Practice and Good Clinical Practice?

Welcome to our team! Join our enthusiastic R&D Quality Assurance team at Schwabenheim, where we uphold GLP, GCP, and GMP compliance in a dynamic global organization. Collaborating with multidisciplinary teams across Pharmaceuticals R&D and various service departments, you’ll work in alignment with both local and international regulations as well as our internal standards. This is a fantastic opportunity for a self-driven professional with a background in life sciences to not only advance their career but also actively shape the veterinary clinical QA profile and contribute to a streamlined and supportive QA infrastructure at our innovative research and development location. If you thrive in an international setting and seek personal development, we invite you to explore the exciting role of R422577 Clinical Quality Specialist / Auditor (m/w/d) - befristet auf 2 Jahre.

We are seeking an experienced QA Auditor to support our R&D Quality Assurance and veterinary clinical R&D department in ensuring compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations. The successful candidate will review clinical study and clinical trial material documentation, perform internal and external audits, and provide guidance in a GxP regulated environment. This is a unique opportunity to join our R&D Quality Assurance team on a 2-year fixed-term contract as maternity leave cover.

• Review veterinary clinical studies to ensure compliance with regulatory standards and internal processes.
• Conduct internal and external audits in accordance with GxP guidelines to assess compliance and identify areas for improvement.
• Support qualification activities in line with GMP requirements and review qualification documentation for accuracy and completeness.
• Apply extensive knowledge and experience in risk management to identify, assess, and mitigate potential risks in processes.
• Assist in maintaining and improving the GxP quality system to ensure ongoing compliance and operational excellence, including Standard Operating Procedures (SOPs) and training.
• Collaborate effectively within a team, demonstrating strong communication skills and the ability to work in an intercultural and interdisciplinary environment.
• Demonstrate a proactive and independent work ethic, with strong self-organisation and planning skills to manage tasks efficiently and meet deadlines.

• Master’s degree or higher in Life Sciences or a related field.
• First years of experience in regulated GxP environment and QA auditing knowledge.
• Proven experience in quality assurance within the pharmaceutical sector, particularly in GCP and GMP environments.
• In-depth knowledge of regulatory requirements and industry standards for veterinary medicinal product development, complemented by strong compliance and documentation skills in a regulated environment.
• Proven risk management expertise, with a successful track record in implementing effective risk mitigation strategies.
• Excellent interpersonal and communication skills, enabling effective collaboration across diverse teams and the establishment of strong relationships with key stakeholders and leadership.
• Proficiency in digital tools and technologies for document management and quality assurance processes, alongside innovative problem-solving and critical thinking abilities.
• Ability to work independently with exceptional self-organisation and planning skills to enhance quality assurance practices.
• Good written and verbal communication skills in German and English.

Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry’s most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.

What We Offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development.

• Competitive salary
• 30 days of leave
• Solid Pension Plan
• Bonus plan subject to the company annual results
• Flexible working arrangements including hybrid working model

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

• Aseptic Manufacturing
• Audits Compliance
• Corrective and Preventive Action (CAPA)
• Detail-Oriented
• Documentation Review
• Driving Continuous Improvement
• GMP Compliance
• Quality Assurance Tools
• Quality Auditing
• Quality Management Systems (QMS)
• Quality Standards
• Root Cause Analysis (RCA)
• Supplier Quality Management
• Troubleshooting

Employee Status

Project Temps (Fixed Term)

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/11/2026

A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R422577