Quality Assurance Manager

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Job Introduction

Quality Assurance Manager (QA Manager)

Cramlington

We are looking for:

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.

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.

At Pharmaron we offer:

• Vibrant and dynamic employment - we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and exciting!
• 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!

Requirements:

Experience:

• 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.

Education:

• Degree or equivalent in Chemistry or a related scientific discipline - Desirable

Key roles and 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.

Our Company:

"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. We take pride in our professionalism and commitment to always deliver our very best work.

Our Cramlington site, just north of Newcastle, has an established history of cGMP

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 state of the art working environment on site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes.

Why Should You Apply?

• 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.
• Build and shape your career in an environment that sets and commits to the highest standards.
• 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. With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.