Join to apply for the Senior Director, GCP QA role at Tessera Therapeutics .

Ready to make your application Please do read through the description at least once before clicking on Apply. Get AI-powered advice on this job and more exclusive features. Minimum Qualifications: 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 Tessera. 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. Your Experience Includes: Developing and implementing a comprehensive GCP quality system. Being the first in the GCLP QA unit and scaling with Tessera 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. About You: 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. Leadership Structure: All inquiries regarding the posted position should be directed to the Talent Partner. Interested individuals must apply directly to be considered for the opening. Company Summary: Tessera Therapeutics is pioneering Gene Writing—a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. More about Tessera Therapeutics: Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate.

#J-18808-Ljbffr