Director, Clinical Quality Assurance - Waltham, United States - Dyne Therapeutics

Dyne Therapeutics Waltham, United States

5 days ago

Full time

Description

Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

Role Summary:

The Director of Clinical Quality Assurance is responsible for leading Good Clinical Practice (GCP) Quality Assurance (QA) and serves as the GCP Quality representative for clinical study teams. This leader is skilled at building GCP processes and has in-depth knowledge of current GCP practices. This individual is the subject matter expert in GCP, is responsible for developing standards and partnering with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures. This role ensures compliance with applicable regulations with regards to sponsor oversight of Dyne's clinical programs. This role is responsible for continuing to build out the quality infrastructure and evaluate, identify, and reduce compliance risk by contributing to the development and maintenance of efficient and effective clinical quality procedures to achieve the highest level of data quality and integrity.

This is a full-time position based in Waltham, MA without the possibility of being remote and requires ~25% travel.

Primary Responsibilities Include:

Provide leadership and operational management for all Dyne Clinical Quality Assurance (CQA) activities to provide assurance of subject protection and data integrity under GCP regulations including Clinical QA audit program development and management, Clinical Quality issue management, Clinical QA SOP development and maintenance, General GCP training, GCP Regulatory inspection preparation and management, Keep leadership apprised of changes to the clinical quality compliance landscape affecting business performance

Prepare and implement risk-based audit plans for clinical studies. Coordinate/perform and/or support GCP auditing activities and observation resolution to ensure that studies are conducted in accordance with the study protocols, regulations and GCP

Collaborate with Clinical Operations, clinical sites and CROs to provide ongoing quality support and oversight during the set-up, conduct and completion of clinical studies to ensure participant safety and data integrity

Lead the GCP inspection readiness/inspection support activities at the CROs and clinical sites

Perform CQA reviews of clinical study protocols, Brochures, Patient Information Sheets / Informed Consent and Assent forms, and other related clinical study documents as needed

Develop, establish, and implement GCP clinical quality assurance (CQA) oversight and management processes and procedures

Write, review and approve SOPs associated with Clinical Operations and Development

Support the Quality group's oversight efforts with quality systems such as change control, quality investigations, CAPA identification and resolution, audits, and any other recommendations to compliance issues and/or observations as they arise

Report and escalate significant quality observations/risks to leadership

Facilitate and/or conduct internal clinical quality training for employees and contractors

Lead resolution of CGP compliance issues

Assess adequacy of GCP activities by planning and overseeing the execution of a comprehensive GCP quality assurance audit program

Ensure US CQA audits are aligned with organization's local and global procedures

Ensure efficiency in CQA processes that support and drive continuous quality improvement

Facilitate GCP quality issue management and assesses adequacy of proposed corrective and preventive actions (CAPA)

Provide GCP compliance advice and support to Clinical Development

Identify and communicate to senior management the trends impacting clinical quality

Recommend changes to policies and procedures that improve quality and efficiency

Embrace latest technology to enhance visualizations of quality assurance metrics that facilitate better decision-making

Facilitate continuous learning and knowledge transfer with team members

Serve as the point of contact in managing GCP audit collaboration with vendors and sites

Provide support and advice to organizations in preparing for and through participation in GCP inspections

Educational and Skills Requirements

Bachelor's degree or higher in a relevant field such as life sciences, nursing, pharmacy, or public health

10+ years of relevant experience in pharmaceutical or biotechnology

8+ years Good Clinical Practice and Quality Management System experience

Experience in development and implementation of Clinical Quality Management Systems for GCP

Excellent Microsoft Office (Word, Excel, Smartsheet, PowerPoint, Outlook) skills

Familiarity with common applications used in management of GCP Quality Management activities

Strong analytical skills and problem-solving capabilities

Advanced communication and interpersonal skills (e.g., conflict resolution, teamwork, impact and influence, communication, etc.)

Ability to create and deliver informative and persuasive presentations to internal team members, external parties, and organization's executive leaders

Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is proactive and willing to jump in to support Dyne QA activities

Excellent organizational skills with the ability to prioritize, work with minimal supervision, proactively identify areas for improvement, and drive initiatives from identification to completion independently

Ability to develop and apply creative solutions to complex issues, and adapt to changing needs and situations

#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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