Senior Associate Director, QMS & Compliance

Catalent; Swindon; On-site; GBP 110,000 - 140,000; Full time

Benefits offered by this job

Bonus & Benefits

Pension scheme with up to 8% match

Life assurance

Cycle to Work

Job summary

Catalent Swindon site seeks an Associate Director, QMS & Compliance to lead the Quality Management System and regulatory affairs, ensuring GMP/FDA/MHRA compliance and continuous improvement at a leading biologics/pharmaceutical operations hub in Swindon, UK.

You will develop high-performing teams, manage QMS budgets, and partner with customers and suppliers to meet quality objectives while upholding the company’s values and ethics.

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Physical Sciences, or a related field.
• Significant pharmaceutical industry experience with leadership and people management.
• Strong customer focus, stakeholder management and client-facing skills.
• Excellent problem-solving, risk management, change management, and technical writing skills.
• Leadership experience at Catalent or participation in leadership programmes may be considered in lieu of external leadership experience.

Responsibilities

• Lead and maintain the Quality Management System (QMS) and ensure GMP, FDA, MHRA and other regulatory compliance.
• Oversee regulatory affairs activities including regulatory filings, DMF maintenance, and responses to inquiries.
• Ensure site compliance with Manufacturer/Importer Authorisations and Wholesale Dealer Licences.
• Drive operational excellence through QMS budgets, resources, cost reduction and continuous improvement.
• Develop, coach and lead a high-performing team with training and succession planning.
• Collaborate with customers, suppliers and internal stakeholders to support quality and business objectives.

Skills

Leadership capability

Customer focus

Problem solving

Risk management

Technical writing

Education

Degree in Pharmaceutical Sciences/ Chemistry/ Physical Sciences

Job description

Catalent Swindon site seeks an Associate Director, QMS & Compliance to lead the Quality Management System and regulatory affairs, ensuring GMP/FDA/MHRA compliance and continuous improvement at a leading biologics/pharmaceutical operations hub in Swindon, UK.

You will develop high-performing teams, manage QMS budgets, and partner with customers and suppliers to meet quality objectives while upholding the company’s values and ethics.