Quality Manager

Culina; Greater London; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Annual Leave 25 days

Private Medical Cover

Pension scheme

Life Assurance 4x salary

Employee assistance programme

Job summary

Great Bear, part of the Culina Group, seeks a Quality Manager to oversee the Compliance and H&S department and ensure GDP compliance for the site. You will lead MHRA audits, maintain GDP documents and CAPA/NCR processes, and drive continuous improvement in quality systems.

Ideal candidates have 3–5 years as RP in pharma, strong GDP/H&S knowledge, and excellent communication. The role involves coordinating training and reporting quality metrics within a fast-paced logistics environment.

Qualifications

• Minimum 3–5 years as RP in medical/pharmaceutical sector.
• Strong GDP and regulatory knowledge.
• Experience in quality management systems and audits.
• Attention to detail and strong communication.

Responsibilities

• Maintain GDP compliance across site operations.
• Lead MHRA, client and corporate audits.
• Develop and maintain GDP documentation and procedures.
• Manage CAPA and NCR processes.
• Oversee change control and validation programs.
• Review temperature controls and QA release processes.
• Coordinate training programs for staff.
• Prepare and present quality metrics at QM Reviews.

Skills

GDP compliance

H&S compliance

MHRA RP

Audits

CAPA & NCR

Change control

Documentation review

Training programs

Education

RP qualification

Tools

Microsoft Office

Job description

Company Description

Great Bear (Part of the Culina Group) provides distribution services to FMCG clients. Customer centric service focus is delivered through a site-level empowered culture. At Culina we have a winning culture, we believe that our culture is one of the reasons our company continues to thrive A place where you're valued, challenged, and inspired!

Job Description

As a Quality Manager you will be responsible for managing the Compliance and H&S department and ensuring the overall GDP compliance of the site. You will have a key responsibility in maintaining and developing all aspects of compliance management and Health & Safety profile of the site. Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate compliance with EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (#####/C 343/01) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.) Named as the primary Responsible
Person on the WDA(H) and Controlled Drug licence Maintain and continually improve the companys Quality Management System in compliance with current MHRA GDP guidelines, applicable certifications and group policies and procedures. Responsible for the generation, revision, approval of procedures and other GDP documents Responsible for creation of annual audit programme, performance of RP audits and management of self-inspections. Ensure that any subcontracted activities which may impact on GDP are approved Act as the lead contact for MHRA, client and corporate audits Responsible for creation and review of Technical Agreements CAPA and NCR management. Responsible for management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome. Review and approve validation protocols and ensure that all systems are validated Decide on the final disposition of returned, rejected or falsified products Coordinate and promptly perform any product recall operations Management of risk assessment programme and ensure that the mitigation strategies are defined and implemented Responsible for change management. Ensure that change control process in place for documentation, processes and systems Oversee sampling and quality assurance release of products Ensure that initial and continuous training programmes are implemented and maintained Review and sign off temperature records and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursions Host Quality Management Review meetings, collate monthly Quality stats and produce compliance reports. Manage team of 3 (Compliance and H&S Manager and 2 QA Specialists)

Qualifications

You will ideally have a professional background and previous experience (minimum 3-5 years) as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirement of an RP Quality Manager experience
Knowledge and experience of applying GDP guidelines and H&S Experience in examining and reengineering procedures and developing and implementing new strategies and procedures Effective time management Strong attention to detail Strong interpersonal and communication skills Confidence and assertiveness Excellent IT skills (including Microsoft Office packages) Dynamic and self-motivated, keen to achieve excellence within the business

Additional Information

As part of our drive to make Great Bear a great place to work. We are proud to be an inclusive and diverse organisation where we are committed to employee development and recognising success for hard working performers. Our dedicated learning and development programmes are open to every employee to give you the opportunity to shape your own future within logistics and continue to work in an environment where team culture thrives. Our People are the driving force behind our success, which is why we offer a wide

Benefits

range of benefits which include:

• Annual Leave 25days plus the normal 8bank holidays.
• Company Bonus We do our best work to succeed together. When we achieve our goals you'll be rewarded through our bonus scheme.
• Private Medical Cover This gives you peace of mind, you have choice, flexibility and speed of access to the most clinically appropriate care via Bupa.
• Pension scheme we want colleagues to enjoy a comfortable retirementso we offer agreat contribution of 5%employee and 8% employer.
• Life Assurance - 4 x your annual salary.
• Wellness Via our Employee Assistance Programmewe offer immediate access to a confidential telephone counselling and legal information service that operates 24 hours a days, 365 days a year.
• Eye Care Vouchers We can provide you with substantial savings with free eye tests and discounts in prescription glasses.
• Reward & Recognition We recognise that employees have gone the extra mile via Employee of the month and year, special recognition and long service awards.
• Everyday discounts - via our benefit platform you will have access to over 50 retailer discounts for everyday savings!