Quality Manager GCP
Immunocore

Conshohocken, Pennsylvania

Posted in IT


Job Info


About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesThe Role:

The Quality Manager- GCP role will support the execution of Quality Assurance activities within the company, overseeing clinical activities relating to the Quality Management System (QMS), and working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as applicable.

This role will also support GCP internal, external, and supplier audits in accordance with international GCP requirements and Immunocore standards, The Quality Manager (GCP) is responsible for working cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.

The ideal candidate will leverage his/her experience, understanding of GCP, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GCP, and regulatory compliance. This role will also require someone who can work within a highly innovative, agile and entrepreneurial environment and is able to effectively collaborate while working under pressure to achieve timelines and ensure compliance with QMS and regulatory requirements.

Responsibilities:

Perform internal and external audits for clinical activities as defined by the QA Audit Schedule.
Support the management and oversight of GCP related activities impacting the QMS.
Lead or participate in audits of suppliers/vendors to evaluate processes, systems and procedures for compliance to GCP requirements and IMC Quality standards.
Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.
Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable.
Evaluate and provide oversight for potential risks, standards and quality principles.
Work cross-functionally with stakeholders across the business to support the escalation and management of Quality Issues, Corrective and Preventative Actions (CAPAs), Root Cause Analysis (RCA), as well as ad hoc issues impacting business processes.
Support Inspection Management Team in preparation for and management of regulatory authority inspections
Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GCP.
Maintain an up to date knowledge and log of applicable legislation and regulatory guidelines.
Provide in-depth quality reviews of data and documentation, as required.
Lead or support the development and/or revision of QA processes and procedures including SOPs and risk assessment tools
Provide training/mentoring on clinical QA as required.
Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
Partnering with functions to find solutions for Quality Issues and audit findings.
Travel 30%.
Participate QA and clinical operational meetings to discuss the status of audits, planned audits, and outstanding CAPAs.
Support the review of metrics as part of quarterly QMS review meeting.
BS with at least 5-10 years' experience with QMS within pharmaceutical and/or biotech industry.

Qualifications:

Essential

Established GCP / QA professional.
Excellent knowledge of GCP (GCLP, GPvP and GMP an advantage).
Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.
Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.
Knowledge of corporate governance, health care regulations, laws and standards.
Strong collaborative, partnering, and interpersonal skills.
Previous experience working in clinical research, biotechnology or the pharmaceutical industry.
Excellent analytical, written and oral communications skills.
Able to foster support and influence all stakeholders throughout the company.
Worked with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).
Worked within Quality Assurance in a similar industry for at least 5 years.

Preferred

Previous experience of managing quality systems in the pharmaceutical or biotechnology industry.
Knowledge of GMP, GLP an advantage.
Knowledge of the industry/clinical trial process and drug development.



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