Senior Director, Quality

What's happening at Entrada Therapeutics? Our mission is to transform the treatment of devastating diseases and improve patients' quality of life using intracellular biologics. Leveraging our proprietary Endosomal Escape Vehicle (EEV)™ platform, we are creating and advancing a diverse pipeline of oligonucleotide, enzyme, protein and peptide programs to efficiently target and engage underlying drivers of diseases.

Our novel approach to drug design and delivery addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the field of intracellular biologics.

We're a tight-knit team of experts and leaders in both therapeutics development and rare disease 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, Quality professional who enjoys helping the organization prepare and meet the regulatory requirements for taking innovative therapies from preclinical stage through to commercialization. You can see the big picture but have a high attention to detail. You recognize that sometimes issues are not black or white and you are comfortable navigating the gray and explaining your rationale to key internal and external stakeholders. You are a strong communicator who speaks with confidence and from experience to colleagues within the organization, external partners and with regulatory agencies. You empower the team to implement things the “right” way instead of taking shortcuts that help you in the short-run but cause trouble down the line. You take accountability for known project responsibilities, but you can also easily adapt and accommodate the unexpected. You thrive in a fast-paced, highly collaborative, flexible working environment

Entrada is seeking a Senior Director of Quality responsible for managing pharmaceutical quality assurance and quality control programs cross-functionally, reporting to the Chief Operating Officer. The successful candidate will develop and manage all quality programs, establish Standard Operating Procedures and oversee continuous improvement as it relates to internal operations and collaborative processes with external vendors. You will play an instrumental role in creating stage appropriate quality systems for pre-clinical to IND enabling work. Additionally, a process for the implementation of training curriculums across the company and training compliance will need to be established.

• Establish the Quality function, define department goals and metrics, and develop and manage quality department budget
• Develop short and long-term plans to achieve both quality and business objectives for the organization
• Establish effective partnerships with cross-functional staff (e.g., regulatory affairs, technical staff etc.) to facilitate the identification and resolution of quality matters and other opportunities for quality process improvement
• Develop the quality policies covering CMC, product development and clinical development 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
• Establish and execute a company-wide compliance training curriculum
• Oversee data archival processes
• Develop, implement, and maintain Entrada’s 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 drive 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:

• Bachelor’s degree in a scientific discipline, advanced degree preferred.
• A minimum of 10 years related QA experience in the pharmaceutical or related industry, including a minimum of 2 years managing a team
• Experience working with contract manufacturing organizations (CMOs), Contract Research Organizations (CROs)
• Must have a comprehensive knowledge of US FDA, EMA, and ICH GCP/GxP regulations related to biopharmaceutical research and development, manufacturing, and clinical activities
• Experience with oligonucleotides is preferred
• 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 desired

By becoming a team member here at Entrada, you’ll 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.