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Qualified Person

3 months ago

Stevenage, United Kingdom Skills Alliance Full time

About

Our client is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Our client has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors.


Why

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at our client you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this our client is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme. Our client promotes flexible working.


Our Promise

Our client is developing complex, breakthrough therapies for a globally diverse market and equally recognizes that diversity amongst our people is critical to our mission. As we draw on our differences, what we have experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees


Role Summary

The Qualified Person is responsible for quality oversight of clinical and commercial activities and Quality Systems by supporting and managing cross-functional relationships with internal and external stakeholders. The incumbent takes the lead on Quality Assurance, GMP Operations and Process Development initiatives and projects. This is a high visibility position in the organization with great impact potential and huge development opportunities.

In addition, the role ensures that our client has a fully functional, effective and efficient quality management system or systems (where required) to manage all GxP activities both on site and at other organizations where a hybrid approach is in place and more than one system is required.

The role is key within the overall Quality organization at our client and ensures that the company remains in compliance with all relevant GxP requirements for all activities supporting development and conduct of clinical trials involving ATIMPs. Reporting to the Executive Director of Quality, the job spans across a number of manufacturing sites plus multiple clinical sites.


Key Responsibilities

• Maintenance of GMP compliance through the application of a continuously improving PQS.

• Clinical and commercial batch release according to EU GMP and UK SI.

• Participate in and drive various companywide GxP projects

• Provide support for our client Trainee QPs in preparation for their visas and for general QP development

• Provide Quality guidance and oversight for multiple GMP and Process Development projects, e.g. onboarding of new facilities and equipment, manufacturing process improvements etc.

• Provide Quality guidance for various stakeholders in the organization, e.g. Regulatory Affairs, Clinical Operations, Process and Analytical Development etc.

• Facilitate and support regular QA governance meetings ensuring that actions associated with Change Controls, Quality Exceptions and Corrective and Preventative Actions (CAPAs) are completed according to agreed deadlines, and that Key Performance Indicators are trended and used to demonstrate control of the PQS, and act when additional control measures are needed.

• Point of contact for relevant MHRA post-Brexit consultations.

• Attend and report to the Quality Board, if required.

• Take part in regulatory interactions with the GMP inspectorates as applicable and if required, e.g. the MHRA, FDA.

• Lead investigations into complaints and quality defects related to products made at the site, interacting with other QPs, and where necessary recall of products batches as determined by QPs and / or clinical trial Sponsor as applicable.

• Provide guidance and training on the interpretation of applicable regulations and industry best practices.

• Manage and approve quality events, including deviations, investigations, and corrective and preventive actions.

• Facilitate and support inspection readiness activities.

• Oversight SOP / Policy documentation system; ensuring that these are all in date and reflect current activities.

• Provide oversight of Good Documentation Practice with the GCP, GScP (Good Scientific Practice), GLP (Good Laboratory Practice) and R&D functions.

• Manage all relevant eQMS systems used at our client within a GxP environment to ensure they are managed in a controlled, traceable and auditable manner and ensure the principles of data integrity are upheld.

• Take part in (and lead, if required) self-inspections, external audits and regulatory interactions with the GxP inspectorates as applicable, e.g. the MHRA, FDA, EMA etc.

Demonstrated skills and competencies

E – Essential

P – Preferred

D – Desirable


Experience

At least 4-10 years’ relevant (ideally industrial) experience in a Quality Assurance role in a PQS, with direct responsibility for maintaining the standards of GMP (E).

• At least 3 years’ relevant (ideally industrial) experience with line management responsibility in a Quality Assurance role (E).

• At least 1 - 3 years’ working in the quality assurance and management of ATMP (D) investigational medicinal product manufacture (P).

• Experience with MHRA (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site.

• Experience in Veeva Platform (D)


Qualifications

• BSc or equivalent experience in pharmaceutical sciences, immunology, biomedical sciences or relevant discipline (P).

• EU / UK Qualified Person (E)

Skills/Specialist knowledge

• Ability to interact with senior leadership in establishing strategic plans, communicating status of key initiatives, including making recommendations and/or attempt to influence decisions in the best interest of the company. (E)

• Strong business acumen with significant business process and/or operational excellence experience, including establishing and managing relationships across all levels of the business. (P)

• Strong functional, organizational and communication skills, with a proven ability to effectively meet deadlines and milestones. (E)

• Ability to effectively oversee and manage external partner relationships, contracts, and service agreements. (E)

• Ability to analyze and define business requirements and translate into technical solutions. (P)

• Ability to communicate ideas in both technical and user-friendly language. (P)

• Effective project management skills are desirable; change management capability and desire to innovate and help lead change. (P)

• Proven adaptability to shifting project schedules, priorities, and assignments; able to make effective decisions under pressure. (E)

• Demonstrated self-directed, problem solver in a dynamic, fast-growing, fast paced, team environment. (E)

• Experience working in a team-oriented, collaborative environment. (E)

• Desktop Application literacy required; MS Office skills (Outlook, Word, Excel, SharePoint(E)

• Life Sciences industry experience preferred. (P)

• In depth understanding of effective, efficient quality management systems and ability to drive through changes and improvements as required (E)


Leadership Behaviors (incorporating Core Competencies)

Clarify direction and inspire; Using good judgement to set clear and compelling goals that show your team how their work contributes to our purpose and strategy

Deliver goals and plans; Creating joint plans with your team to deliver your goals, holding yourself and others accountable for delivering quality results

Work collaboratively; Cultivating a network of relationships across the organization and building high performing teams based on mutual trust and respect


Optimize potential; Creating a healthy, engaged and empowered working environment that invests in people and their development.


Role Model our values; Acting as a role model ensuring everything you do is in line with our values of respect, integrity, focus and breakthrough is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR)


Pay Rate: 173 Euros per Hour