Senior Quality Systems Lead – GMP, Audits & Compliance

Baxter International Inc.; Packmoor; On-site; GBP 50,000 - 70,000; Full time

Benefits offered by this job

Competitive total compensation package

Professional development opportunities

Work life balance

Job summary

A global healthcare company is seeking a Snr Quality Systems Associate to ensure compliance and lead quality initiatives in the UK. This role focuses on quality system support and continuous improvement within the compounding business. Candidates should have a Bachelor’s degree in a relevant field and at least 2 years of experience in the pharmaceutical or medical device industry. Strong project management and communication skills are essential. The position offers a competitive compensation package and emphasizes work-life balance.

Qualifications

• English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5.
• At least 2 years’ experience in the pharmaceutical or medical device industry.
• Proven knowledge of Quality System processes.
• Minimum of 2 years’ experience in quality team facilitation or project management.
• Experience in coordinating Document Control and Internal Audit processes.

Responsibilities

• Ensure compliance with applicable GMP, GDP, MHRA, and regulatory standards.
• Lead development and continuous improvement of the Quality Management System.
• Review stability studies and product documentation.
• Own and lead Temperature Excursion Evaluation Tasks.
• Support regulatory reporting of quality issues.

Skills

Quality System processes

Project management

Process improvement

Quality data analysis

Root Cause Analysis techniques

Report and documentation writing

Verbal and written communication

Education

Bachelor’s degree or higher in Pharmaceutical, Biotechnology, Chemistry or Microbiology

Tools

TrackWise

Job description

A global healthcare company is seeking a Snr Quality Systems Associate to ensure compliance and lead quality initiatives in the UK. This role focuses on quality system support and continuous improvement within the compounding business. Candidates should have a Bachelor’s degree in a relevant field and at least 2 years of experience in the pharmaceutical or medical device industry. Strong project management and communication skills are essential. The position offers a competitive compensation package and emphasizes work-life balance.