Work with us
Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.

Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Job Description:

Job Title: Senior Specialist I, QA Clinical

Reports to Director, QA Clinical

Department: Quality

Hours: Full Time

Location: Stevenage, Remote/Hybrid

About Autolus

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on 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 designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Why Autolus

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 Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership, and teamwork. In addition to this Autolus 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. Autolus promotes flexible working.

Our Promise

Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises 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 (Senior) Clinical Quality Assurance Specialist I is responsible for quality oversight activities within Clinical development by supporting and managing cross-functional relationships with business process owners and external stakeholders. Maintains Quality Assurance oversight in Clinical Operations and Clinical Development. This is a high visibility position in the organisation with great impact potential and huge development opportunities. In addition, the role also supports compliance of the Autolus quality management system.

The role is key within the overall Quality organisation at Autolus and ensures that the company remains compliant with GCP / GVP regulations, including activities supporting clinical trials involving ATIMPs. This role encompasses oversight and support of quality system types including paper, electronic or hybrid. Reporting to the Director, GCP QA, the job’s reach spans across several manufacturing sites plus multiple clinical trials.

Key Responsibilities

• Support the development and implementation of the risk-based audit plan for GCP/GVP-regulated activities.
• Support the planning, conduct and follow-up activities of audits for vendors, contract research organisations (CROs), clinical investigator sites, trial master file, and internal business processes within clinical development and operations.
• Oversee the qualification, onboarding, oversight, and offboarding of clinical vendors in collaboration with contract owners.
• Provide QA support to Clinical project teams.
• Support the development and maintenance of the quality management system in conjunction with the Quality team and other stakeholders.
• Manage, review, and approve quality events, including deviations, investigations, and corrective and preventive actions pertaining to the GCP/GVP area.
• Authoring, review, and approval of Clinical QA and GxP procedural documents
• In collaboration with relevant stakeholders develop, implement, maintain, and improve policies, procedures, and associated plans for Clinical QA.
• Promote Good Documentation Practice within clinical project functional areas.
• Support the administration of the Trial Master File TMF system (including but not limited to user management, configuration, and validation).
• Support the management of the QMS (Veeva) and eTMF (Trial Master File) platform and related applications and technologies.
• Administration management of all relevant eQMS systems used at Autolus within a GCP environment to ensure they are managed in a controlled, traceable, and auditable manner and ensure the principles of data integrity are upheld.
• Collaborate with stakeholders to identify process gaps and recommend solutions.
• Provide GCP/GVP metrics on compliance and present at quality review meetings and/or functional meetings.
• Assist with regulatory inspections e.g., MHRA, FDA, EMA etc Including inspection co-ordination activities.
• Support clinical inspection readiness activities.

Demonstrated skills and competencies

E – Essential

P – Preferred

D – Desirable

Experience

• At least 1 – 3 years’ experience of clinical compliance or QA experience in pharmaceutical, CRO, biotech industries or hospital settings. (E)
• At least 1 years’ experience in operating, management and administration of an electronic quality management systems and / or electronic documentation management systems (eDMS); ideally in a Pharmaceutical or Medical Device environment. (D)
• At least 1 - 3 years’ experience in a Quality related role; ideally in a Pharmaceutical or Medical Device environment (E).
• Experience with MHRA or other regulatory inspections (P).
• Experience in eTMF systems (P)

Qualifications

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

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

Autolus Core Competencies

Focus on Results:Works to meet business goals set by management and leaders

Builds Trust and Relationships:Ensures trust with internal and external partners by delivering on commitments

Resilience:Has the capacity to recover quickly from difficulties; toughness

Communicates and Collaborates:Builds partnerships and works collaboratively with others to meet objectives

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.