ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
The Associate Director, GCP Quality Assurance, will have the responsibility to serve as a subject matter expert to ensure that all quality and regulatory compliance related to GLP/GCP, pharmacovigilance, and other related activities performed by Medical/Clinical Departments. The incumbent will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GLP/GCP guidelines, and applicable international and national standards, regulations and guidelines. Act as a quality representative during regulatory agency inspections and vendor audits.
Essential Duties and Responsibilities
- Assists in the implementation of GLP/GCP compliant procedures and operations to ensure a robust quality management system for clinical studies
- Proactively provides GCP QA support to Clinical Operations and other departments based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices
- Assists with the organization, preparation, coordination, and documentation of regulatory inspections
- Participating in the evaluation and qualification of CRO's and other GLP/GCP pharmacovigilance service providers
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs), addressing root causes
- Reviewing and approving audit plan, audit observations and assessing the adequacy of CAPAs
- Sharing responsibility with the team for GLP/GCP training
- Assisting with the preparation, coordination, and management of regulatory agency inspections
- Developing, reviewing and updating QA SOPs for GLP/GCP compliance, as needed
- Schedules and conducts Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) Audits of systems and processes related to preclinical and clinical operations, and pharmacovigilance
- Provides GLP/GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites
- Reviews and provides input to clinical documentation (protocols, study reports, IB)
- Ensure timely identification, escalation, and resolution of quality and compliance issues
- Contribute to process improvement initiatives across the organization - provide support and direction to maintain a quality system to recognized standards - direct and/or participate in the development of QA processes and SOPs - support development of processes and SOPs by process owners outside QA
- Bachelor's degree in Life Sciences. Advanced degree preferred.
- 8-10 years of relevant pharmaceutical industry experience in GCP/clinical quality assurance with a minimum of 5 years of Good Clinical Practices (GLP/GCP) auditing experience. Global Clinical QA experience is desired
- Expertise include Phase 1 - Phase 4 clinical trials, clinical investigator site audits, vendor audits
- Strong working knowledge and interpretation of FDA / EU and ICH – GLP/GCP regulations and guidelines
- Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
- Capable of collaboratively engaging with external, third parties to effectively ensure the intentions of our Quality System are fulfilled
- Excellent interpersonal and communication skills
- Strong computer skills, including all MS Office applications
- Ability to operate within and simultaneously build a QMS
- Effectively interact with multi-disciplinary functional groups
- Outstanding written and verbal skills as well as problem-solving skills
- Strong initiative and ability to assume significant project management skills
- Ability to work in a fast-paced, dynamic environment
- >30% Travel may be required for this position
- Ability to write reports, presentations and email correspondence