Director, Clinical Quality Assurance at Dyno Therapeutics

Waltham, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in a scientific, allied health, or medical field required; Master’s degree preferred
Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)
Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
Broad clinical development experience across all phases (Phase I through BLA/NDA)
Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
Proven experience developing and implementing risk-based clinical quality assurance programs
Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
Skilled at effectively communicating quality events and outcomes to internal stakeholders
Excellent interpersonal, verbal, and written communication skills
Working knowledge of multiple therapeutic areas is a plus
Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
Flexible and creative

Responsibilities

Inform and contribute to audit planning and strategy
Perform and/or coordinate clinical site and vendor audits
Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
Support inspection readiness activities and co-host regulatory inspections
Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
Conduct and/or manage the qualification and oversight of service providers
Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
Support investigational new drug (IND) applications and related correspondence with global regulatory authorities

Skills

Key technologies and capabilities for this role

GCP complianceaudit planningvendor oversightCAPA managementroot cause analysisinspection readinessregulatory inspectionsGCP trainingquality risk managementdeviation managementKPIs

Questions & Answers

Common questions about this position

Is this role remote or based in a specific location?

This role is based in Waltham, MA without the possibility of being a remote role.

What education and experience are required for this position?

A Bachelor’s degree in a scientific, allied health, or medical field is required, with a Master’s degree preferred, along with a minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role.

What are the main responsibilities of the Director, Clinical Quality Assurance?

The role involves leading GCP compliance, developing risk-based strategies, managing audits and inspections, overseeing vendors, supporting inspection readiness, and ensuring global regulatory compliance.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Strong candidates will have a Bachelor’s or Master’s degree in a relevant field, 10+ years in pharma/biotech with 5+ years specifically in Clinical Quality Assurance, and expertise in GCP compliance, audits, inspections, and regulatory interactions.

Dyno Therapeutics

Develops AI-optimized gene therapy vectors

About Dyno Therapeutics

Dyno Therapeutics focuses on advancing gene therapy by utilizing Artificial Intelligence to create Adeno-associated virus (AAV) vectors. These vectors are essential tools for delivering genetic material into cells, which is crucial for effective gene therapy. The company's AI technology enables the design and optimization of these vectors, potentially enhancing the success of gene therapies. Dyno collaborates with major pharmaceutical and biotech companies, such as Astellas, Roche, Sarepta, and Novartis, to develop therapies for various diseases affecting the skeletal and cardiac muscles, central nervous system, liver, and eyes. Unlike many competitors, Dyno's unique approach leverages AI to improve the performance of AAV vectors, setting it apart in the biotech field. The company's goal is to improve gene therapy outcomes through its advanced vector technology, ultimately benefiting patients with serious health conditions.

Watertown, MassachusettsHeadquarters

2018Year Founded

$106MTotal Funding

SERIES_ACompany Stage

AI & Machine Learning, Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Remote Work Options

Risks

Gene therapy investment slowdown may impact Dyno's growth and innovation.

Manufacturing bottlenecks could hinder scaling of Dyno's operations.

Increased competition from companies like Form Bio challenges Dyno's market position.

Differentiation

Dyno uses AI to design optimized AAV vectors for gene therapy.

Their AI-driven CapsidMap platform enhances AAV vector development for muscle gene therapies.

Partnerships with major pharma companies like Astellas and Roche boost Dyno's market presence.

Upsides

AI-driven capsid design improves delivery efficiency and reduces manufacturing costs.

Collaboration with NVIDIA enhances biological sequence design for gene therapies.

Generative AI increases efficiency of eye and brain-targeted capsid delivery significantly.

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