Overview
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 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 – 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 – you will enjoy your work.
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.
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
Our Company
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has established diverse drug R&D service capabilities across multiple disciplines and operates with over 21,000 employees globally.
Location: Cramlington site, just north of Newcastle, with cGMP manufacturing services for APIs and related development activities.
Why Should You Apply?
* This is an opportunity to make a real impact in a highly scientific and regulated environment, demonstrating leadership and ambition.
* Build and shape your career in an environment that commits to the highest standards.
* Join a team that supports each other and solves technical challenges with excellence.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, offering capabilities spanning chemistry, biology, DMPK, pharmacology, drug safety, radiochemistry, and development to clinical support. With operations in China, the US, and the UK, Pharmaron employs over 21,000 people worldwide.
Job function
* Quality Assurance
Seniority level
* Mid-Senior level
Employment type
* Contract
Industries
* Pharmaceutical Manufacturing
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