Executive Director, Quality - Boston, United States - Entrada Therapeutics

Description

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

You are an experienced QA leader who is intellectually curious and can bring new ideas and perspectives to our growing team. You like to work collaboratively with other cross-functional stakeholders and aren't scared to roll up your sleeves when needed. You follow up and follow through, efficiently connecting problems with solutions.

As the Executive Director of Quality Assurance, you will play a pivotal role in shaping and implementing our quality strategy across all aspects of our operations. Reporting directly to the President & COO, you will be responsible for ensuring compliance with regulatory requirements, fostering a culture of continuous improvement, and maintaining the highest standards of quality throughout our organization.

• Evolve and scale the QA function, with a focus on the development of systems and policies. Define department goals and metrics that align with the corporate objectives.
• Establish effective partnerships with cross-functional departments and leaders (e.g., regulatory affairs, CMC, Clinical Operations, and Product Development) to facilitate the identification and resolution of quality matters and other opportunities for quality process improvement.
• Develop short and long-term plans to achieve both quality and business objectives for the organization.
• Develop and manage quality department budget.
• Develop the quality policies consistent with current regulatory expectations for rare diseases and ensure that the quality policies and objectives are clearly communicated, implemented, and maintained within the organization.
• Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues.
• Monitor key quality metrics, analyze insights, and report findings to senior management during management reviews.
• Develop, implement, and maintain Entradas quality management system as appropriate for the development stage of the product and in compliance with US FDA, EMA and other international regulatory agencies regulations and expectations.

At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

Bachelors degree in a scientific discipline, advanced degree preferred.
12+ years related QA experience in the pharmaceutical or related industry, including a minimum of 4 years managing a team.
Experience with oligonucleotides is required.
Expertise and ability to lead/oversee all GxP related needs.
Experience working with contract manufacturing organizations (CMOs) and Contract Research Organizations (CROs) is required.
Must have a comprehensive knowledge of US FDA, EMA, and ICH GCP/GxP regulations related to biopharmaceutical research and development, manufacturing, and clinical activities.
FDA-facing experience in managing inspections and experience in conducting internal and external audits including GLP and GMP vendor audits.
Proficient in the development and utilization of quality systems (e.g., deviations and investigations, change control, CAPA, training, CTMS, TMF).
Quality auditor certification (CQA) desired.
ASQ certification and/or Six Sigma preferred.

By becoming a team member here at Entrada, youll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Entrada Therapeutics, Inc. (the Entrada, we, us, or our) respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.