ADQA - 2018
US ~ Miami
Associate Director, GCP Quality Assurance
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The Associate Director, GCP QA is responsible for implementing and maintaining 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 audit, and serves as the point of contact and host for all regulatory inspections. The Associate Director, GCP QA promotes a GCP compliant environment with internal and external stakeholders while ensuring established quality systems are employed.
Qualifications & experience required for competent performance
- Bachelors in a scientific or life sciences discipline. A healthcare background and/or an advance degree preferred.
- A minimum of 6+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP quality role, clinical monitoring or equivalent with at least 3 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.
- Excellent oral and written communication skills.
- Strong root cause analysis/problem solving, risk assessment and impact analysis abilities.
- Flexible and able to delegate, multi-task and prioritize competing demands/work load.
- Excellent communication, negotiation, conflict management, and cross-functional facilitation skills.
- Fluent in English
- Proficient with MS Office
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.
- Identify, communicate, and escalate risks, study violations, and serious non-compliance situations. Provide direction 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, analyze 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 CGP 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.
- Perform other duties as assigned.