Manager, Quality Assurance GCP

BioSpace; Gaithersburg (MD); Remoto; USD 125.000 - 150.000; Tempo pieno

Descrizione del lavoro

Immunocore is seeking a Manager of Quality Assurance GCP to lead audits and oversee GxP compliance across global clinical activities. This role requires deep expertise in GCP, GCLP and GPvP, with strong QMS governance and risk management capabilities.

The role covers audits of suppliers, data integrity, regulatory inspections, and continuous improvement of QA processes within a biotech environment. Travel up to 30% is expected as part of responsibilities.

Competenze

• Established GCP / QA professional.
• Excellent knowledge of GCP, GCLP, GPvP.
• Strong understanding of quality management systems (GxP) to ensure compliance with regulatory requirements.
• Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.

Mansioni

• Perform audits for clinical activities per QA Audit Schedule.
• Support management of GCP and GVP related activities impacting the QMS.
• Lead or participate in supplier audits to ensure GxP compliance.
• Prepare audit plans and report findings to leaders.
• Assist in managing core clinical QA processes and risk assessment.

Conoscenze

GCP / QA

GxP knowledge

QMS metrics

Analytical skills

MS Office

Communication skills

Clinical research experience

Formazione

Bachelor’s degree or equivalent

Descrizione del lavoro

Vacancy Name Manager, Quality Assurance GCP Vacancy No VN694 Employment Type Full Time Location of role Gaithersburg, MD, Radnor, PA, Oxford, UK, Remote, US Department Clinical QA

KEY RESPONSIBILITIES

• Perform internal and external audits for clinical activities as defined by the QA Audit Schedule.
• Support the management and oversight of GCP and GVP related activities impacting the QMS.
• Lead or participate in audits of suppliers/vendors to evaluate processes, systems and procedures for compliance to GxP requirements and Immunocore 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, including ICH E6 (R3) 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, continuous improvements
• 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% OTHER DUTIES
• 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.
• Attend and contribute to action items identified as part of weekly Quality Monitoring meetings.

SUPERVISORY RESPONSIBILITY

This position has no supervisory responsibilities

Experience & knowledge Essential

• Established GCP / QA professional.
• Excellent knowledge of GCP, GCLP, GPvP (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 Experience & knowledge

• 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.

Education & qualifications

• A minimum of 5 to 10 years’ related experience within pharmaceutical and/or biotech industry
• Bachelor’s degree or equivalent combination of education and experience US Salary Range $125,000 - $150,000

About the Company

Immunocore (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. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.