Director, GCP Quality Assurance

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Director, GCP Quality Assurance

Job Code:USRA006

Position: Director, GCP Quality Assurance

Department: Regulatory Affairs

Reports to:  Senior Director, Quality Assurance

Location: CA (SF Bay Area or San Diego)

Company Profile:

Connect Biopharma (Nasdaq: CNTB) is a global, clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research.  With clinical development activities in the United States, China, Europe, and Australia, and operations in those geographies as well as Hong Kong, Connect Biopharma is building a rich global pipeline of internally designed, wholly owned small molecules and antibodies targeting several aspects of T cell biology.

Job Summary:

Director, GCP, Quality will play a critical role in providing the leadership and strategic vision in managing Quality/compliance related to GCPs, and pharmacovigilance. This key role is responsible for overseeing CROs and maintaining clinical trials and internal GCP compliance. This is a hands-on position where the successful candidate works with minimum guidance to ensure that the clinical studies are per applicable laws and regulations.

Responsibilities

  • Provide quality oversight of GCP activities across multiple clinical CROs and other service partners as appropriate, supporting early/late-stage clinical development to protect the safety of patients and data integrity.
    • Provide guidance and advice related to quality guidelines (ICH, FDA, EMA), GCP, and compliance to internal clinical teams.
    • Evaluate, qualify, and conduct audits of clinical CROs, investigator sites, and other service providers to ensure compliance with internal corporate procedures and applicable global GCP regulations.
    • Perform internal and external audits to assess compliance gaps for GCP-related clinical operations.
    • Report audit findings to the management. Recommend an effective plan to correct GCP gaps, create a CAPA plan, and evaluate its effectiveness for inspection readiness.
    • Create, revise, develop, and continuously improve control documents (Policies, GCP protocols, Trial Master Files, SOPs, Forms, ICFs, CRFs, etc.).
    • Provide quality and compliance guidance to the clinical team in decision-making to meet regulatory requirements.
    • Participate in budget planning, including identifying and allocating essential expenditures.
    • Prepare, review, and negotiate GCP-related quality agreements as appropriate.
    • Establish Inspection Readiness activities and metrics and serve as a key inspection host and be the primary point of contact for GCP Quality Systems during audits and inspections.
    • Support/review Regulatory filings as needed.
    • Work collaboratively with various functional stakeholders in a matrix environment to drive continuous improvement initiatives and excellence.

Education

Minimum of a BA/BS is required. An advanced degree is preferred.

 

Qualifications And Requirements

  • The ideal candidate will possess at least 10 years of in-depth knowledge and experience in GCP Quality Assurance and Quality Compliance within the pharmaceutical and/or biotech industry, including at least 5 years of experience in management and/or leadership roles.
    • A thorough understanding of quality and regulatory requirements related to GCP (ICH, EU, FDA, EMA) and processes for drug development, the conduct of clinical trials, and oversight of CROs/investigator sites are required.
    • A clear understanding of early and late phase Quality systems/processes with expertise in GCPs and PV is required; GMP knowledge of GMPs is preferred.
    • Early and late-phase experience with developing both small and large molecules is required.
    • Experience in a virtual company overseeing CROs, investigator sites, and other clinical service providers.
    • Ability to collaborate in a multinational environment to achieve shared goals and objectives; prior experience building Quality functions within an emerging global company is also an advantage.
    • Experience in combination device products (PFS, autoinjector) is a plus.
    • Strong critical thinking, problem-solving, influencing, and communication skills.
    • The ability to multi-task, prioritize options, anticipate challenges, and execute on goals as an interdisciplinary global team member is essential.
    • Excellent organizational, written, and verbal communications.
    • Proficient with MS Office applications required; experience with document management systems is a plus; previous experience with EDMS systems is an advantage.

We offer our employees the opportunity to grow individually while working collaboratively to make a difference in the lives of the patients we seek to serve.