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.
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.
Experience Requirements
* 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
* 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)
Benefits
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.
Equal Opportunity & Diversity
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.
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