Manager, GMP Quality Assurance (CONTRACT)

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- and protein-based programs for the potential treatment of neuromuscular and ocular 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 analytical and detail oriented.  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 an excellent team player and relationship builder.

The Opportunity

The Manager, GMP Quality Assurance (CONTRACT) will be responsible for supporting late-stage GMP QA activities and transitions through PPQ to commercial launch.  This includes overseeing master and executed batch record review and disposition of drug substances and drug products (including package and labeling). The position is also responsible for owning or supporting deviations, change controls, and CAPAs and ensuring a strong quality process for successful product commercialization.

Responsibilities

• Support critical manufacturing and laboratory investigations, PPQ strategy development, and regulatory interactions, ensuring a strong quality process and inspection readiness.
• Lead or support preparatory work for Heath Authority inspections and actively support inspection interactions.
• Review and approve master and executed batch records, ensuring final disposition compliance with regulatory filings and internal specifications where applicable.
• Review in-process, release, and stability data.
• Disposition lots from intermediates through finished drug product.
• Supports internal and external deviations, change controls, and CAPAs to closure.
• Monitor evolving regulatory requirements and quality trends to ensure GMP Quality readiness and proactive compliance planning.
• Support Vendor Management Program, including management of vendor audit activities and the Approved Supplier List.
• Writes and implements changes to GMP Standard Operating Procedures.
• Delivers expertise and guidance to drive continuous improvement of standardized processes for managing GxP documents/records. 
• Performs the appropriate QA review/approval of SOPs, SOP-related documents, and Policies. 
• Leads and supports understanding and adoption of risk-based approaches and decision making.
• Interacts with cross-functional teams across technical operations as a QA lead or resource.
• Supports all GxP functions as needed.  

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:

• Bachelors in a relevant scientific field and a minimum of 5+ years of QA experience in pharmaceutical or biotechnology companies. Experience can be considered in lieu of degree.
• Strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of future cGMP commercial practices.
• Proven experience contributing to Health Authority regulatory filings and successful inspection readiness and support for EMA or FDA.
• Demonstrated