What are the responsibilities and job description for the Senior Director, GCP QA (Somerville, MA) position at CEDENT?
Your Experience Includes…
You are a strong leader with extensive experience in GCP QA, ideally within the gene therapy field. You have a proven track record of building and leading successful Clinical QA teams and a deep understanding of GCP regulations and guidelines. You are passionate about ensuring the quality and integrity of clinical trials and are committed to fostering a culture of compliance and continuous improvement. Your experience aligns perfectly with the responsibilities of this role, and you are eager to contribute to the success of a rapidly growing and innovative gene therapy company. You have experience interfacing with external CROs, research institutes/universities, clinical sites. You have demonstrated success in building strong platforms and collaborative teams.
Client leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves.
- Minimally a Bachelor's Degree in a scientific discipline or related field with [12-15 ] years of industry experience.
- Significant expertise and experience overseeing CROs in support of early phase clinical trials, including being first in function.
- It’s strongly encouraged to have a GLP background to support preclinical activities at Client.
- It's a bonus if you have experience in the gene therapy field, certification in quality assurance (e.g., CQM, CQA), and experience with EDC systems and other clinical trial technologies.
- Developing and implementing a comprehensive GCP quality system.
- Being the first in the GCLP QA unit and scaling with Client as we grow.
- Providing strategic guidance and oversight to ensure GCLP compliance.
- Conducting and overseeing internal and external audits.
- Managing the investigation and resolution of quality issues.
- Collaborating with cross-functional teams.
- Staying updated of evolving regulatory requirements.
- Contributing to regulatory submissions and other clinical trial documents.
- Establishing and maintaining strong relationships with key stakeholders.
You are a strong leader with extensive experience in GCP QA, ideally within the gene therapy field. You have a proven track record of building and leading successful Clinical QA teams and a deep understanding of GCP regulations and guidelines. You are passionate about ensuring the quality and integrity of clinical trials and are committed to fostering a culture of compliance and continuous improvement. Your experience aligns perfectly with the responsibilities of this role, and you are eager to contribute to the success of a rapidly growing and innovative gene therapy company. You have experience interfacing with external CROs, research institutes/universities, clinical sites. You have demonstrated success in building strong platforms and collaborative teams.
Client leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization and themselves.
