GCP QA Manager

Job Title:GCP QA Manager
Location UK ~ Nottingham
UK ~ Homebased
Type: Full Time

Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing, clinical and data sciences facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

The Role

We have an exciting opportunity for a GCP QA Manager to join our QA department in Nottingham. This is a full time role. The successful applicant will be responsible for managing the GCP QA team and oversight of all aspects of GCP QA, including Phase 1 accreditation, and the site’s Quality Management Systems to assure continued compliance with all UK and global regulations, standards, global and local company policies and procedures. You will be required to comply and adhere to GXP guidelines and regulations as required of this role whilst working effectively with colleagues across all functional areas to achieve objectives whilst maintaining good working relationships.

Other responsibilities will include:

· To manage the GCP QA team and ensure operational excellence and ensuring GCP Quality representational cover to meet the required workload commitments.

· To provide leadership, encouragement, support, positive reinforcement and job enrichment opportunities to direct reports by undertaking regular 1:1s, objective setting and performance reviews

· Provide excellent QA customer service and great communication for internal and external stakeholders

· Review, improve and harmonise processes to ensure compliance with GCP, increased effi-ciency and adherence to KPIs for the GCP QA team

· Support the scheduling of team tasks to ensure the efficient utilisation of resources and com-pliance with strict timelines:

· Generation, review and approval of SOPs

· Performing and supporting audits (internal & sponsor) to ensure compliance with GCP and internal procedures

· Supporting the vendor management programme by ensuring appropriate GCP resource is as-signed and by the performance of vendor assessments and audit (of suppliers and subcontrac-tors)

· Review and/or investigation into Quality Issues

· GCP point of contact for CAPA, blinding material, audits (study compliance and clinical study report), change controls, file notes, questionnaires and other GCP compliance activities

· Development and delivery of GCP training to staff in conjunction with others in the Quality Management Team

· Support GCP regulatory inspections as required

· Encourage continuous improvement and innovative ways of working, whilst maintaining GCP compliance

· Be team-aligned and represent Quality at key project stage gates.

· Maintain a presence with operational areas to promote relationships and trust

· Bulid on knowledge continually by keeping abreast on regulatory requirements, industry best practice and Quality organisational effetiveness

The Candidate

We are looking for a GCP QA Manager who is a strong people manager who will thrive in a fast-paced working environment, with the ability to prioritise workloads and identify and drive continuous improvements.

Skills and experience required:

· Science-based HND or degree

· Minimum of 5 years’ experience in a QA role in pharmaceutical or clinical research roles

· A good working knowledge and understanding of Good Clinical Practice (GCP)

· Proven ability to lead a group of individuals in group scenarios

· Experience and knowledge of Quality Management Systems (QMS) and applicable regulations to comply with GCP

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast paced and dynamic business.

Our Commitment to Diversity & Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome