Quotient Sciences Limited
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
Assure successful outcomes of client audits and regulatory inspections by managing the sites compliance status, proactively identifying, and working collaboratively to resolve compliance risks, and maintaining an effective GCP Quality Management System. Serve as audit host for client audits and regulatory inspections. As required, lead the resolution of and response to any audit/inspection findings. Effectively communicate audit and inspection outcomes to site and Executive Management. Perform detailed review of policies, procedures, work instructions, quality issues, CAPAs, vendor management documents and other essential documents. Assure the control of documents is maintained so only current, approved versions are accessible to personnel; assure periodic review of procedures and work instructions; assure QMS documents, internal, 3rd party and vendor audit records, and study-related documents are appropriately archived. Perform detailed review of policies, procedures, work instructions to assure compliance to standards and efficient and effective practices. Assure the control of documents is maintained so only current, approved versions are accessible to personnel; assure periodic review of procedures and work instructions; assure quality records are appropriately archived. Serve as a champion for the effective use of the QMS (training, procedures, quality issues, CAPA) across the site. Identify, communicate, and escalate risks, study violations, and serious non- compliance situations. Provide directions for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency. Assure timely issuance of corrective and preventive actions (CAPAs) in response to quality issues and audit observations. Monitor completion of CAPAs to assure thorough root cause investigations, appropriate and effective actions, and timely execution. Assure GCP training programs are established, implemented, and maintained for all personnel. Compile metrics, analyse trends and identify and assure implementation of improvement initiatives. Assure site metrics are reported to site and global management. Continuously remain up to date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on GxP quality and compliance related issues. Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives. Serve as a champion for the effective use of the QMS (training, procedures, quality issues, CAPA) across the site. Establish annual QA department objectives that align with site objectives and global QA objectives. Generate individual objectives that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) for staff that assure successful achievement of department objectives. Facilitate an environment that allows employees to succeed in their roles. Coach and develop staff and encourage continued professional development. Conduct communication and feedback sessions through team meetings and one-on-one interactions to assure staff receives appropriate direction, feedback and coaching for success. Develop productive, dynamic, professional working relationships with site `personnel and colleagues in other global Quality Assurance functions. Assure that client projects are properly staffed with knowledgeable QA resources who serve as engaged and responsible project team members that contribute to the timely execution of projects, the customer's satisfaction, and assure regulatory requirements are fulfilled. Plan, direct and, as necessary, conduct internal compliance audits to assure compliance to company policies and procedures. Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility. Plan, direct and, as necessary, conduct external compliance audits of vendors. Assure timely resolution of any identified non-compliances to minimize risk to quality and supply of products and/or services. Develop productive, dynamic, professional working relationships with site personnel and colleagues in other global Quality Assurance functions. Provide full and timely QA support to internal and external customers. Perform other duties as assigned. Qualifications and experience required for competent performance
Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advanced degree preferred. A minimum of 8 years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role, clinical monitoring or equivalent with at least 5 years in quality. Knowledge of applicable Global GCP regulations, Good Clinical Practices, ICH Guidelines. Clinical trial audit experience is a must. Demonstrated audit conduct experience is required, including experience supporting regulatory authority inspections. Ability to compile and interpret quality metrics. Self-directed and able to work effectively across multiple global cultures and with cross functional teams. Strong root cause analysis/problem solving, risk assessment and impact analysis abilities. Proven leadership experience with the ability to inspire and motivate (ideally >10 years line management experience) Strong working knowledge of GxP and quality systems. Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others. Ability to manage performance of the function across multiple sites and deliver results. Skilled in thinking and acting strategically. Excellent communication, negotiation, conflict management, and cross-functional facilitation skills.
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.
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
Assure successful outcomes of client audits and regulatory inspections by managing the sites compliance status, proactively identifying, and working collaboratively to resolve compliance risks, and maintaining an effective GCP Quality Management System. Serve as audit host for client audits and regulatory inspections. As required, lead the resolution of and response to any audit/inspection findings. Effectively communicate audit and inspection outcomes to site and Executive Management. Perform detailed review of policies, procedures, work instructions, quality issues, CAPAs, vendor management documents and other essential documents. Assure the control of documents is maintained so only current, approved versions are accessible to personnel; assure periodic review of procedures and work instructions; assure QMS documents, internal, 3rd party and vendor audit records, and study-related documents are appropriately archived. Perform detailed review of policies, procedures, work instructions to assure compliance to standards and efficient and effective practices. Assure the control of documents is maintained so only current, approved versions are accessible to personnel; assure periodic review of procedures and work instructions; assure quality records are appropriately archived. Serve as a champion for the effective use of the QMS (training, procedures, quality issues, CAPA) across the site. Identify, communicate, and escalate risks, study violations, and serious non- compliance situations. Provide directions for and assure appropriate and timely resolution of violations and non-compliances, acting always with an appropriate sense of urgency. Assure timely issuance of corrective and preventive actions (CAPAs) in response to quality issues and audit observations. Monitor completion of CAPAs to assure thorough root cause investigations, appropriate and effective actions, and timely execution. Assure GCP training programs are established, implemented, and maintained for all personnel. Compile metrics, analyse trends and identify and assure implementation of improvement initiatives. Assure site metrics are reported to site and global management. Continuously remain up to date with the latest industry changes to regulatory requirements and industry standards. Provide consultancy on GxP quality and compliance related issues. Represent GCP Quality Assurance on compliance-related projects and initiatives. Where assigned, lead such projects and initiatives. Serve as a champion for the effective use of the QMS (training, procedures, quality issues, CAPA) across the site. Establish annual QA department objectives that align with site objectives and global QA objectives. Generate individual objectives that are SMART (Specific, Measurable, Attainable, Realistic, Time-bound) for staff that assure successful achievement of department objectives. Facilitate an environment that allows employees to succeed in their roles. Coach and develop staff and encourage continued professional development. Conduct communication and feedback sessions through team meetings and one-on-one interactions to assure staff receives appropriate direction, feedback and coaching for success. Develop productive, dynamic, professional working relationships with site `personnel and colleagues in other global Quality Assurance functions. Assure that client projects are properly staffed with knowledgeable QA resources who serve as engaged and responsible project team members that contribute to the timely execution of projects, the customer's satisfaction, and assure regulatory requirements are fulfilled. Plan, direct and, as necessary, conduct internal compliance audits to assure compliance to company policies and procedures. Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility. Plan, direct and, as necessary, conduct external compliance audits of vendors. Assure timely resolution of any identified non-compliances to minimize risk to quality and supply of products and/or services. Develop productive, dynamic, professional working relationships with site personnel and colleagues in other global Quality Assurance functions. Provide full and timely QA support to internal and external customers. Perform other duties as assigned. Qualifications and experience required for competent performance
Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advanced degree preferred. A minimum of 8 years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role, clinical monitoring or equivalent with at least 5 years in quality. Knowledge of applicable Global GCP regulations, Good Clinical Practices, ICH Guidelines. Clinical trial audit experience is a must. Demonstrated audit conduct experience is required, including experience supporting regulatory authority inspections. Ability to compile and interpret quality metrics. Self-directed and able to work effectively across multiple global cultures and with cross functional teams. Strong root cause analysis/problem solving, risk assessment and impact analysis abilities. Proven leadership experience with the ability to inspire and motivate (ideally >10 years line management experience) Strong working knowledge of GxP and quality systems. Must possess strong written and oral communication skills, ability to influence change/be a change agent, and be able to coach, mentor and train others. Ability to manage performance of the function across multiple sites and deliver results. Skilled in thinking and acting strategically. Excellent communication, negotiation, conflict management, and cross-functional facilitation skills.
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.