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Senior Manager, GLP Quality Assurance (CONTRACT)

Boston, MA

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, 50 and 51 skipping amenable. Entrada has 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.

The Perfect Addition to Our Team

You are enthusiastic about lab quality assurance, whether it is in the regulated GLP/GCLP environment or the product development side of pharmaceuticals. You are passionate about joining a growing organization where your knowledge and experience will be highly valued. You thrive in a collaborative environment, working with others to enhance infrastructure throughout the organization. You appreciate growth and collaboration opportunities while sharing your expertise with others learning from their strengths and skills as well. You follow up and follow through, efficiently connecting problems with solutions.

The Opportunity

The Senior Manager, GLP Quality Assurance will support in-house laboratory operations and outsourced GLP/GCLP activities.  The role will heavily collaborate and influence internal laboratory, vivarium, and toxicology teams and activities to advance their infrastructure.  This individual will provide Entrada with a dedicated quality partner throughout the product development phase of programs, supporting discovery work through GLP studies/GCLP analyses across internal and outsourced laboratories.

Responsibilities

  • Build a fit-for-purpose Quality Management infrastructure for internal laboratory operations in collaboration with Discovery, Product Development, Pharmacology, and Toxicology teams.
  • Provide quality oversight of GLP and GCLP partners by attending vendor meetings, leading implementation of the appropriate procedures for Sponsor oversight, and supporting or leading the review and approval of the documentation.
  • Provide in-house expertise and support for non-GxP lab teams to assure data integrity of internally generated laboratory data used in regulatory authority interactions and submissions.
  • Review SOPs, data, and reports, as needed.
  • Lead Quality Event activities such as investigation, root cause analyses, and CAPA development and ensure appropriate documentation.
  • Collaborate and educate cross-functionally to ensure successful implementation of new processes and procedures.
  • Partner with Quality Vendor Management to support audit activities.

The Necessities

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:

  • A BS/BA with 7 + years of relevant pharmaceutical or biotechnology experience, with 4 + years working directly in GLP Quality Assurance.
  • Strong knowledge of GLP/GCP regulations. Previous experience working in relevant laboratory and vivarium settings is preferred.
  • Demonstrated ability to function in a fit-for-purpose environment.
  • A risk-based mindset with previous experience operating in small company environments.
  • Excellent verbal and written communication skills.
  • The ability to work effectively across functions.
  • Desire to work in an innovative, fast-paced, and collaborative team and company.
  • Ability to travel approximately 15% of the time, as determined by the needs of the business.
  • This role will align to our hybrid working model, with an expectation of 3 days per week on site in our Boston, MA office. #LI-JF1

The Perks

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.

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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.

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