Senior Specialist, Quality Assurance - Hybrid

MSD Ireland; West Point (AL); Hybrid; USD 75,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Quality Assurance to join their dynamic team. This hybrid role involves ensuring the timely and compliant regulatory release of clinical supplies for global trials. The ideal candidate will leverage their expertise in clinical trials and regulatory requirements to support a wide array of clinical development programs. With a focus on collaboration and continuous improvement, you will play a key role in enhancing operational excellence and ensuring compliance across various teams. If you are passionate about quality assurance and thrive in a fast-paced environment, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in the pharmaceutical industry.
• Strong understanding of supply release processes.

Responsibilities

• Ensure compliance with regulatory release of clinical supplies.
• Collaborate with various teams for process improvement.

Skills

Knowledge of clinical trials

Regulatory requirements

Problem-solving skills

Quality assurance background

Attention to detail

Effective teamwork

Excellent communication skills

Education

Bachelor’s Degree in a scientific discipline

Job description

Senior Specialist, Quality Assurance - Hybrid

Join to apply for the Senior Specialist, Quality Assurance - Hybrid role at MSD Ireland.

**Job Description**
The Clinical Supplies Quality organization, within our Research & Development (R&D) Division, is responsible for assuring the reliable availability, quality, and regulatory compliance of clinical supplies to support our clinical development programs. This includes over 300 in-house Phase I-IV clinical trials, 400+ outsourced trials, 200+ IIS clinical trials, and 200+ external collaborations across 60+ countries, all in compliance with worldwide regulations and company policies.

**Role Overview**
The Clinical Trial Regulatory Release auditor will be responsible for the timely and compliant regulatory release of clinical supplies supporting global trials. This involves collaboration with Global Clinical Supply, Global Clinical Trial Operations, Regulatory Affairs, and Quality functions to develop and implement country-specific release activities.

**Key Responsibilities**

• Regulatory release of clinical supplies in accordance with procedures.
• Assess country-specific requirements to ensure compliance.
• Support the development and revision of procedures.
• Work with various teams to ensure robust processing and continuous improvement.
• Implement and improve end-to-end release processes with Global Development Quality.
• Contribute to projects aimed at reducing cycle times and enhancing operational excellence.

**Qualifications and Skills**

• Knowledge of clinical trials and regulatory requirements.
• Ability to manage multiple priorities with a sense of urgency.
• Strong problem-solving skills and proactive challenge management.
• Background in quality assurance, auditing, or regulatory affairs.
• Attention to detail and understanding of the supply release process.
• Effective teamwork and independent working skills.
• Excellent written and oral communication skills.

**Education & Experience**
Bachelor’s Degree in a scientific discipline with at least 5 years of relevant experience in the pharmaceutical industry.