Senior Director, GCP Quality Assurance

Quotient Sciences : Molecule to Cure. Fast.

We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average.

Arcinova , our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept.

Why join us?

Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast.

The Role

We are looking for a skilled and motivated Senior Director of GCP Quality Assurance to lead our clinical quality operations at our Miami site.

Summary of Job Purpose

• To comply & adhere to GXP guidelines and regulations as required of this role.
• Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.
• Responsible for implementing, maintaining, and continuously improving Good Clinical Practice (GCP) compliance programs and the Quality Management Systems (QMS) to support the clinical trial activities at Quotient Sciences Miami.
• Provides QA oversight to assure clinical trial activities are conducted in compliance with applicable regulations, ICH GCP guidelines, and internal policies and procedures. Manages and conducts internal and supplier audits, hosts client audits, and serves as the point of contact and host for all regulatory inspections.
• Promotes a GCP compliant environment with internal and external stakeholders while ensuring established quality systems are employed.
• To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards.
• To ensure subject safety at all times
• Responsible for providing leadership, oversight, and functional management to the Miami Site and Quality Assurance team. Ensure company's adherence to current Good Clinical Practices (cGCPs), Good Documentation Practices, regulatory requirements, and internal procedures and practices for pharmaceutical development, and clinical studies.
• This role is classified as Exempt
• To comply & adhere to GCP guidelines and regulations as required of this role.

Main tasks and responsibilities

Qualifications and experience required for competent performance

10 years line management experience)

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and / or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

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