Senior Manager, Clinical Quality Assurance
Department: 110 CMCLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
Role Summary:
The Senior Manager of Clinical Quality Assurance (QA) will be responsible for leading GCP QA that provides QA support to clinical study teams. This leader will be skilled at building GCP processes and has in-depth knowledge of current GCP practices. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures. This role will ensure compliance with applicable regulations with regards to sponsor oversight of Dyne’s clinical programs.
This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders including Clinical Development, Clinical Operations, Regulatory Affairs, and Project Management.
Primary Responsibilities Include:
- Collaborate with manager and stakeholders to define and build the GCP QA capability designed to support Dyne’s clinical portfolio while maintaining a strong independent role for QA decision-making
- Develop appropriate procedures and documentation to ensure standards, practices and policies and procedures are in compliance with applicable laws and regulations
- Support the development and implementation of the QA vision, goals, core capabilities, and value while championing a strong Quality Culture
- Provide GCP training
- Manage domestic and international audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Dyne quality standards
- Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed. Ensure audit reports and corrective actions are developed and completed within mandated timelines
- Assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready
- Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
- Support the development of the Quality Management System framework for Clinical Operations
- Establish and maintain Clinical Quality metrics. Present metrics and escalate systemic and/or critical problems to management
- Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation, with a focus on critical and major quality events
- Support investigational new drug applications and related correspondence from global regulatory authorities
- Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes
Education and Skills Requirements:
- GCP QA professional with broad drug experience which spans all clinical phases (Phase I to BLA/NDA)
- Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
- A proven track record of demonstrating good judgement & decision-making experience
- Excellent organizational skills
- Ability to concisely present quality events and the criticality to internal stakeholders
- Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
- Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA
- A working knowledge of the therapeutic area would be beneficial
- Bachelor’s degree in a scientific discipline is required
- 10+ years of relevant experience in a biotech/pharmaceutical setting including a GCP role
- Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources. Consistently delivers
- Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet GMP as well as clinical compliance
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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