Quality Assurance Manager – Pharmaron – Cramlington, UK
An experienced and proactive Quality Assurance Manager to join our team in Cramlington. In this key leadership role, you’ll ensure our site meets the highest GMP standards expected of an API manufacturer. You’ll be responsible for maintaining and improving the Quality Management System in line with guidelines, managing audits, and providing expert QA oversight across all site activities.
Responsibilities
* Lead, manage, and develop the QA team through training, mentoring, and performance reviews.
* Ensure site activities comply with GMP regulations, company policies, and the Quality Management System.
* Act as QA SME during audits, regulatory inspections, and customer visits; host and coordinate audits as required.
* Review batch documentation and analytical data, ensuring compliance with release requirements; carry out batch disposition as delegated.
* Manage key quality systems including deviations, CAPAs, change control, complaints, and supplier qualification.
* Oversee internal audit programmes and ensure compliance with ICH Q7 and ISO9001:2015 standards.
* Provide QA input into validation, cleaning, and qualification activities, including authorising protocols and reports.
* Support regulatory inspections and lead customer escalations and investigations.
* Drive continuous improvement initiatives and ensure training needs are identified and addressed.
Qualifications
* Minimum 5 years’ experience in Quality Assurance roles within a GMP-regulated environment.
* Strong understanding of regulatory requirements and proven ability to resolve compliance challenges.
* Demonstrated leadership skills and experience managing teams.
* Excellent organisational skills, attention to detail, and ability to prioritise effectively.
* Degree or equivalent in Chemistry or a related scientific discipline – Desirable.
Benefits
* Vibrant and dynamic employment – a highly specialised, growth company operating in a critical sector of the economy.
* Opportunities to develop your skills and yourself – rapid growth brings greater opportunities to learn and grow faster.
* A great team where we all support each other – enjoy your work – after all you spend about a third of your time here.
* Competitive salary and a progressive and comprehensive suite of employee benefits.
* State of the art working environment on site.
* Opportunity for growth and development and support funding for relevant training and development programmes.
Pharmaron is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment.
#J-18808-Ljbffr