Senior Director, GCP QA

Your experience includes… 

• 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.

You are interested in… 

• 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. You have experience interfacing with external CROs, research institutes/universities, clinical sites. You have demonstrated success in building strong platforms and collaborative teams.

Tessera 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.

Leadership Structure: 

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.  

Ian O’Reilly, Vice President, Quality- I have learned that focusing on people and establishing strong teams is paramount to a successful tenure at any company.  I have a passion for creating Quality units and building relationships within the corporate community, always striving to be better.  Novel therapeutics and the hope they bring to their patient populations is a powerful reason to focus and deliver. With 20 years of experience within the biotechnology field, most recently focusing on curative therapies, I enjoy working with extremely motivated professionals who know there’s a better way forward for medicine and is driven by building and developing quality assurance principles in a company that poses great personal and professional growth.

Meet our Leadership Team and Board of Directors 

Meet your Talent Partner:

Annie Edminster, Employee Experience and Talent Lead- Originally from Maine, Annie obtained her Bachelor of Science from Syracuse University. She spent eight years in Biotech, Engineering and Tech agency recruitment, then joined Tessera in 2022. Annie loves watching her new hires grow in their careers and getting to know her colleagues from all over the world! She lives in New Hampshire with her robot-building husband, two feisty daughters, and two Siberian cats.  

 

Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.

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. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthrough