Quality Assurance Manager (QA Manager)
An experienced and proactive Quality Assurance Manager to join our team in Cramlington. 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.
This is an excellent opportunity for someone who thrives in a regulated environment, enjoys leading teams, and is passionate about driving quality excellence and continuous improvement.
Opportunities to develop your skills and yourself - our rapid growth brings greater opportunities for you 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!
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.
Degree or equivalent in Chemistry or a related scientific discipline - Desirable
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; Review batch documentation and analytical data, ensuring compliance with release requirements; Manage key quality systems including deviations, CAPAs, change control, complaints, and supplier qualification.
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.
We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world's leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges".
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. manufacturing services for an array of Active Pharmaceutical Ingredients (API), ranging from pilot scale to commercial metric ton scale. The Cramlington Site has more than 100 cubic meters reactor commercial capacity and has been inspected and approved by the MHRA, FDA and other regulatory authorities. The site operates from small scale in the laboratory through to large manufacturing scale. It also offers chemistry and analytical development service.
We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
This is an opportunity for you as a Quality Assurance Manager to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development.