Director, Quality GCP & GLP

The Perfect Addition to Our Team

You are driven and enthusiastic.  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 review clinical trial specific documents and GLP reports.   

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 Opportunity

Entrada is seeking a Director, GCP/GLP Quality to manage GCP and GLP quality assurance activities.  This role will ensure quality and compliance of Entrada’s development programs with respect to clinical and nonclinical studies.  The position is based in Boston, MA and reports directly to the Head of Quality.  

Responsibilities

• Lead the clinical and nonclinical QA functions to enhance the Quality System in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements, and industry practices. 
• Identify controlled document improvements, creation and training needs within the GCP/GLP. 
• Collaborate and provide QA expertise in processes such as investigations, corrective and preventive action (CAPA) plans, trial protocol deviations, complaints, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review. 
• Represent QA on clinical study teams and conduct QA review of clinical study protocols, study plans and protocol deviations Vendor Qualification, Auditing and Monitoring. 
• Design and execute risk-based audit plans/schedules in collaboration with clinical and nonclinical study teams, including establishment of appropriate quality compliance criteria, to assure compliance with regulations, guidelines, and standards. 
• Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts. 
• Conduct internal audits to assess effectiveness of Entrada’s GCP/GLP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits.
• Timely issuance of audit plans, audit reports, audit observations, oversee audit response process and drive audits to closure.
• Evaluate audit observation trends and compliance risks and escalate to QA Management, as required.
• Lead inspection readiness by strategizing, collaborating, executing, plans and tasks to prepare and support impacted programs/study teams.
• Ensure the clinical and nonclinical sites are audit ready and compliant at all times.
• Participate (eg, host/co-host inspections, lead or support inspection back-room/preparation room activities) during external and regulatory agency inspections.
• Develop and Report key quality metrics, periodic quality reports and audits as needed.
• Ensure timely collaboration with Entrada staff to ensure any non-compliance is elevated appropriately and addressed in a timely manner.
• Conduct and coordinate annual GCP/GLP trainingOther Duties/Requirements. 
• Works cross functionally to solve problems and produce solutions that work for the broader team. 
• Works across all levels in the organization to deliver GCP/GLP Quality compliance. 
• Partners with external collaborators, contractors, and contract research organizations to fully support drug development activities.
• Lead continuous improvement initiatives. 

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:

• BS in a scientific discipline, advanced degree preferred with at least 10 years of experience in pharmaceutical / biotech / clinical research industry with significant experience in GCP/GLP environment.  
• Strong knowledge of GCP, GCLP, GLP, GVP, and ICH clinical requirements. 
• Prior experience with clinical and nonclinical studies and CRO oversight. 
• Experience with US and international clinical studies. 
• Prior regulatory inspection experience required (eg, hosting inspections, inspection readiness planning and execution, etc.) 
• Working current knowledge of Quality Assurance methodologies.
• Able to collaborate, influence and work effectively across multiple departments. 
• Able to make decisions based on company and/or quality policies and procedures. 
• Strong data gathering, metrics development, and report generation skills.
• Strong analytical and problem-solving skills; strategic-thinker. 
• Strong organizational skills and ability to work independently. 
• Strong verbal and written communication skills. 
• Highly effective interpersonal skills. 
• Excellent MS Office, Adobe Acrobat Pro skills.
• Demonstrated ability to lead people in a positive manner. 
• Demonstrated ability to manage multiple and diverse projects concurrently. 
• Demonstrated ability to develop positive relationships and collaborations. 
• Conscientious and extremely detailed oriented.
• Strong ability to create practical and efficient processes. 
• Able and willing to work at Entrada site, attend meetings, etc., on an as needed basis. 
• Able and willing to travel, up to 25% – domestic and international, consistent with project needs.