Specialist, Quality Assurance - Hybrid

MSD in the UK; London; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An innovative firm is seeking a Specialist in Quality Assurance to join their Clinical Supplies Quality organization. This role is pivotal in ensuring the compliance and quality of clinical supplies for global trials. You will be responsible for regulatory releases and improving processes in collaboration with various teams. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with excellent problem-solving and communication skills. This position offers a hybrid working model, allowing you to balance your professional and personal life effectively.

Qualifications

• 2 years of relevant industry experience in clinical trials and regulatory requirements.
• Background in quality control, assurance, auditing, or regulatory affairs.

Responsibilities

• Ensure regulatory release of clinical supplies for global trials.
• Collaborate to enhance the release process and operational excellence.

Skills

Regulatory compliance

Problem-solving

Attention to detail

Teamwork

Communication skills

Education

Bachelor’s Degree in a Scientific Discipline

Job description

Join to apply for the Specialist, Quality Assurance - Hybrid role at MSD in the UK

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 in support of 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, in accordance with worldwide regulations, company policies, and SOPs.

Responsibilities

• Regulatory release of clinical supplies, ensuring compliance with applicable procedures to support global clinical trials.
• Assess country-specific requirements and conditions set by health authorities for compliant release of clinical supplies.
• Support the authoring of procedures.
• Collaborate with various business areas to ensure robust processing and continuous improvement of the release process.
• Implement and improve end-to-end release processes in partnership with Global Development Quality.
• Contribute to projects aimed at reducing processing cycle times and enhancing operational excellence.

Qualifications

• Understanding of clinical trials and regulatory requirements.
• Ability to manage multiple priorities with a sense of urgency.
• Problem-solving skills and proactive challenge management.
• Background in quality control, assurance, auditing, or regulatory affairs.
• Attention to detail and awareness of the supply release process.
• Teamwork and independent working skills.
• Strong communication skills.

Education & Experience

• Bachelor’s Degree in a Scientific Discipline with 2 years relevant industry experience.
• Familiarity with batch disposition activities is preferred.