Job description

Director, Clinical Quality Assurance GCP

Rockville, Maryland, United States

DIRECTOR, CLINICAL QUALITY ASSURANCE GCP

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

The Director, Clinical Quality Assurance ensures quality and GCP compliance oversight for all Immunocore Clinical Trial Operations and serves as a liaison to the broader organization to help drive continuous improvement,  compliance, and ensure a culture of quality in clinical operations.  This role also drives continuous improvement and oversight objectives for QA with the goal of ensuring compliance with QMS standards, regulatory policy, legislation, Standard Operating Procedures (SOPs) and other internal processes, as applicable.

This role is responsible for working cross-functionally with Clinical Operations as well as Contract study and other sites to ensure appropriate oversight of clinical trials in alignment with international GCP regulations.    This individual will also assist with identification and timing for 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 and electronic systems relating to clinical operations. 

The ideal candidate will utilize his/her experience, understanding of GCP, and interpersonal skills, to proactively contribute to Clinical Operations and Clinical 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:

  • Support Head of QA to oversee the Quality Management System for GCP.
  • Assist in managing core clinical and QA processes including being owner for some agreed QMS processes, as applicable.
  • Perform internal and external audits for clinical activities as defined by the Internal Audit Schedule and as needed.
  • Perform external vendor/ supplier audits for clinical activities as defined in Audit Schedule and as needed.
  • Assist in other internal audits and external audits, as required.
  • Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.
  • Evaluate and provide oversight for potential risks, standards and quality principles.
  • 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.
  • Facilitate the development, monitoring, and continuous improvement of CAPAs / risk mitigation plans and effectiveness checks.
  • Give consultative assistance to Head of QA and Functional area(s) in relation to clinical QA / risk questions/issues.
  • 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.
  • Support driving and embedding a culture of ethics, integrity and Quality by Design.
  • Provide training/mentoring on clinical QA as required.

This position includes line manager responsibilities- initially for a Senior manager/ manager of Clinical Quality Assurance:

  • Builds, leads and develops a team as needed to ensure GCP QA oversight of Clinical Operations.
  • Promotes communication, cooperation and collaboration across Immunocore to create a sense of purpose and direction across the organisation.

The job holder is expected to support Wholesale Distribution Activities and therefore must be trained and understand the requirements of Good Distribution Practices as defined in Directive 2001/83/EC and various national legislations (e.g., Rules and Guidance for Pharmaceutical Distributors aka The Green Guide).The job holder must have regular and continual training relevant to this role. Training will also include specific aspects of product identification and avoidance of falsified medicines entering the supply chain.  

Qualifications: 

Essential

  • Excellent understanding of Good Clinical Practices (GCP).
  • Experience auditing clinical study sites, experience with TMF Audits, and hosting audits and regulatory inspections.
  • Experience utilizing QMS metrics, KPIs, and QTLs to assess risks to clinical research and drug development processes.
  • Working knowledge of “good practices” (GxP), leading to compliance with regulatory requirements.
  • Previous experience working in clinical research, biotechnology, or pharmaceutical industry.
  • Knowledge of the Industry manufacturing process and drug development.
  • Work collaboratively with existing teams.
  • Able to foster support and influence stakeholders throughout the company.
  • Excellent proven written and oral communication skills.
  • Experience with Microsoft Office at an intermediate level (i.e. Word, Excel, PowerPoint Outlook).
  • BSc with at least 8  years’ experience with GCP compliance, QMS and working within Quality Assurance within pharmaceutical and/or biotech industry.

Preferred Experience & knowledge:

  • Previous experience of managing quality GCP quality in the Pharmaceutical or Biotech industry.
  • Extensive Knowledge of other GxPs, particularly GMP, GDP and GLP.
  • Experience hosting GCP or GCP regulatory agency inspections (e.d. MHRA, FDA, EMA, etc).
  • Knowledge of the Industry/Clinical Trial process and drug development.
  • Familiarity with Human Tissue (HTA) regulations and requirements in EU and UK.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Vision benefits
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.  

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

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