UK ~ Nottingham
Associate Quality Assurance Director/Director, GCP
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to business growth Quotient Sciences has an exciting career opportunity available for an Associate Quality Assurance Director/ Director, GCP .
The Associate Quality Assurance Director/ Director, GCP will be responsible for providing leadership and functional management of the GCP Quality Team, and implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities at Nottingham Quotient Sciences site.
You will provide QA oversight to assure clinical trial activities are conducted in compliance with applicable regulations, guidelines, and internal policies and procedures. You will conduct internal and supplier audits, host client audits, and participate and provide leadership for GCP regulatory inspections. The Associate Quality Assurance Director/ Director, GCP will promote a GCP compliant environment with internal and external stakeholders while ensuring established quality systems are employed.
Main tasks and responsibilities include:
- Providing a strong strategic and practical management of the GCP aspects of Quotient’s quality-related activities to ensure continued compliance with required regulatory standards
- Assisting with the development of strategic plans for the business, in conjunction with other Quotient Site Leadership Team members.
- Leading the GCP Quality Assurance and Internal Monitoring teams with respect to functional line management responsibilities and ensuring GCP Quality representational cover to meet the required workload commitments.
- Facilitating an environment that allows employees to succeed in their roles. Coach and develop staff and encourage continued professional development. Conducting communication and feedback sessions through department/team meetings, and one-on-one interactions to assure staff receives appropriate direction, feedback and coaching for success.
- Assuring successful outcomes of client audits and regulatory inspections by proactively collaborating with other GCP functions to assure compliant quality system execution, identifying and working to resolve compliance risks, and maintaining an effective GCP Quality Management System. Serving as audit host for client audits and regulatory inspections. As required, leading the resolution of and response to any audit/inspection findings and reviewing/approving responses to GCP audits prior to communicating to the auditing body. Effectively communicating audit and inspection outcomes to site and Executive Management.
- Identifying, communicating, and escalating risks, study violations, and serious non-compliance situations. Providing direction for and assuring appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency.
- Collaborating with process owners to conduct thorough and timely root cause investigations into quality issues. Helping identify and implementing effective corrective actions that minimize potential for recurrence of quality issues.
- Reviewing, approving, and assuring continued maintenance of all quality systems procedures and any other procedures relevant to the company’s Phase 1 Accreditation
- Reviewing and approving all major change controls related to clinical operations to ensure regulatory compliance
- Continuously remaining up-to-date with the latest industry changes to regulatory requirements and industry standards. Interpreting and communicating GCP regulatory requirements to staff and customers. Providing guidance, development and mentoring to QA and relevant operational staff in GCP requirements and issues.
- Assisting with planning, conducting, reporting and following up of GCP audits (internal and sub-contractor or supplier).
- Delivering GCP training to Quotient staff
- Preparing the monthly QA report for the Site Leadership team
- Participating in customer meetings as required.
- Developing productive, dynamic, professional working relationships with site personnel and colleagues in other global Quality Assurance functions.
- Performing other duties as reasonably required, by Quotient Senior Management/Board.
- Promoting the company and its activities.
The successful candidate will hold a Life Science degree and have a proven track record of managing quality systems within clinical research or the pharmaceutical industry. You will have a thorough knowledge of the regulatory framework in relation to the administration of investigational medicinal products and be comfortable managing change, and implementing systems and procedures across the organisation.
The successful candidate will have previous experience leading a Quality Assurance team in a CRO. You will be passionate about developing your team and ensuring work is delivered to an excellent quality. Phase 1 or Phase 2 experience is desirable for this role as well as:
- Experience and knowledge of GXP Processes and standards.
- Thorough knowledge of Quality Systems in relation to Pharmaceutical, Clinical & Healthcare Industries.
- Extensive experience of managing change and implementing systems and procedures across the company
- Management experience of a Quality Assurance function.
Quotient Sciences offer the opportunity to join a fast paced, growing business in a role that is essential to our long term success. You can expect to work in an empowering and innovative culture alongside a dedicated leadership team, providing strategic insight in your area of expertise. In this role you will make a significant contribution and become part of a company that is truly passionate about transforming drug development.
Due to the nature of this role, the successful candidate will be required to be based onsite in Nottingham. Relocation support will be provided for the successful candidate, along with an attractive remuneration package and plus a range of 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.