Job description

Senior Manager, Clinical Quality Assurance (GCP)

Conshohocken, Pennsylvania, United States

SENIOR MANAGER, 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 Senior Manager, Clinical Quality Assurance will oversee the execution of Clinical Quality Assurance activities within the company, ensuring clinical activities align with GCP expectations and the Quality Management System, and works closely with internal and external colleagues to develop systems and processes in-line with regulatory requirements, GCP, GLP, and internal quality processes, as applicable.

This role will also support GxP internal, external, and supplier audits in accordance with international GxP requirements and Immunocore standards, The Senior Manager, Clinical Quality Assurance) 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 GxP, and interpersonal skills, to proactively contribute to QA oversight activities leading to QMS, GxP, 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:

  • Provide GCP Quality Assurance oversight of clinical activities impacting the Quality Management System.
  • Independently lead internal and external audits for clinical activities as defined by the QA Audit Schedule.
  • Lead or participate in audits of suppliers/vendors to evaluate processes, systems and procedures for compliance to GxP requirements and IMC Quality standards.
  • Prepare audit plans, perform and report audit findings to the auditee, Head of Functional area and Head of QA.
  • Help prepare Investigator Sites for Inspection readiness via On-line or In-Person visits
  • 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.
  • Ensure readiness for FDA and other agency inspections for Clinical Operations, for Immunocore sites, and contracted sites and clinics.
  • Support the Inspection Management Team in preparation for and management of GxP 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 of applicable legislation and regulatory guidelines and provide training to staff on regulatory changes.
  • 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, GCP and GLP standards and expectations as required.
  • Support the review of quality issues and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
  • Partner with functions to find solutions for Quality Issues and audit findings. 
  • Travel up to 20%, primarily US-  International travel may be required to prepare foreign sites for inspections.
  • Participate in QA and clinical operational meetings to discuss status of audits, planned audits, and CAPA extensions.
  • 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.
  • Oversight of contractors and contract auditors.   Future supervisory responsibilities are anticipated.

Qualifications: 

Essential

  • Established GCP  QA professional.
  • Excellent knowledge of GCP (GCLP, GPvP, GLP 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 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:

  • BS with at least 10-15 years’ experience with QMS within pharmaceutical and/or biotech industry.

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

 

Related Jobs

46 vacancies found