Director, GMP Quality Assurance

What's happening at Entrada Therapeutics? Our mission is to transform the treatment of devastating diseases by establishing a new class of medicines to engage intracellular targets that have long been considered inaccessible and undruggable.

Our Endosomal Escape Vehicle (EEV™)-therapeutics represent a fundamental advancement in the field of intracellular therapeutics. They 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 our EEV platform, we are building a diverse pipeline of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, immunological, ocular and metabolic diseases, among others. 

Our lead oligonucleotide programs include ENTR-601-44 and ENTR-601-45 for the potential treatment of people living with Duchenne who are exon 44 and 45 skipping amenable, respectively, as well as our partnered candidate ENTR-701 targeting myotonic dystrophy type 1 (DM1). 

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 analytical and tenacious. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly in order to provide robust and timely solutions.

You are dependable and accountable for your work. You are able to lead teams and develop strategies while not being afraid to roll up your sleeves and perform Batch Release, review and approve Analytical Methods, manage CMO quality documentation and write Quality Plans as needed.

You are an excellent team player and relationship builder. You know when to step in and lead something and when to offer your support. You excel at building relationships and trust with your key stakeholders.

The Director of GMP Quality Assurance will be responsible for strategic and operational management of manufacturing, testing laboratory, and release and distribution-related Quality activities. The scope of this leadership role includes oversight of GMP activities at Entrada and its contract development and manufacturing organizations (CMOs), suppliers, testing laboratories, and logistics vendors. The Director, GMP Quality Assurance is accountable for ensuring that vendors are compliant with global regulations, prepared for potential Sponsor and Regulatory Inspections and that the appropriate processes, systems and activities are in place and performed to protect patient safety, product quality, and data integrity.

This is an exciting, interdisciplinary role for a highly qualified and motivated individual. The successful candidate will have a strong understanding of GMP Quality for raw materials, drug substance, drug product, and label and packaging, including QC testing, stability, and distribution. This expertise, along with drug development background and the organizational and interpersonal skills required to build and foster strong relationships with collaborators, will be needed for success. The ideal candidate will demonstrate the ability to be both detail oriented and to think strategically.

This individual will work to continuously improve GMP quality processes and to support the state of GMP compliance at Entrada. The position will focus initially on GMP Quality build-out to strengthen Clinical-phase Quality Systems, ensuring that systems and processes developed will accommodate global Quality System requirements. 

The position is based in Boston, MA and reports directly to the Sr. Director, Quality Assurance.

Key Responsibilities

• Lead QA oversight of GMP activities at Entrada and its contract development and manufacturing organizations (CDMOs), testing laboratories, and logistics vendors.
• Develop and implement risk-based Quality strategies for investigational and materials including establishment and maintenance of phase appropriate quality systems; proactively identify and mitigate quality risks.
• Be responsible for quality-related activities and requirements to enable release of Raw Materials, Drug Substance, Drug Product, and Finished Goods.
• Oversee GMP/GDP vendor management, assuring that vendors are operating in compliance with the applicable quality program and regulations/ guidelines and are prepared for Regulatory inspections.
• Lead development, implementation, and maintenance of GMP Quality Systems and SOPs related to GMP/GDP activities.
• Lead Quality investigations, including input and approval of plans for resolution of product-impacting Quality issues; provide oversight of appropriate CAPAs associated with investigations, deviations, product complaints and recalls.
• Provide quality input and oversight for process validation, process performance qualification, and continuous process verification.
• Oversee clinical distribution, logistics, and launch activities.
• Collaborate with CMC to establish metrics and report the state of GMP Quality and compliance of GMP vendors to senior management.
• Ensure CMC and GMP/GDP vendor activities are compliant with cGMP, FDA, ICH, EMA regulations and guidelines and industry standards.
• Stay abreast of industry developments – forthcoming regulations, guidance, best practices, and etc., training and mentoring staff on global GMP regulations and guidance.
• Ensure external inspection readiness and pre-approval Regulatory inspection readiness to prepare for audits by external parties and global Regulatory Health Authorities.

• 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:
• Minimum BS degree in Science or Engineering, advanced degree a plus, and 10 years of applicable pharmaceutical drug development experience with at least 8 years of Quality Assurance experience, including Supply Chain QA.
•  Useful background could include experience with oligonucleotides, large molecules, parenteral aseptic fills and filing of an IND/NDA.
• Demonstrated success leading and motivating cross-functional teams and managing direct reports.
• Track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
• Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.
• Strong working knowledge of global GXP requirements, regulations, and guidance; sound judgment and commitment to ethical conduct.
• Excellent leadership skills including an effective written and oral communicator, including experience preparing and making presentations to executive level management and interacting effectively with internal and external organizations, collaborators, and customers.
• Willingness to travel up to approximately 25%.

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.