GCP QA Specialist

Quotient Sciences•Miami, FL

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. 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 Drive and support the Site Quality Management System metrics Support and optimize the development and functioning of Quality Assurance (QA) systems for clinical and scientific research studies to advance the Quality culture. Proactively communicate compliance requirements to the site and serve as a role model for the necessary conduct to maintain compliance with GCP/GxP practices. Ensure efficient and effective implementation of regulatory requirements into the quality management system. Represent Quotient Sciences Quality Assurance function during support of regulatory Inspections as applicable. Plan and execute GDP trainings for the site To comply & adhere to GCP/GxP guidelines and regulations as required of this role.

Requirements

Bachelor’s Degree in a scientific field B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology.
Minimum 6 years of relevant experience in life sciences quality or relevant experience in a regulated field
Strong subject matter expertise in quality management systems, GCP requirements, ICH E6, ICH E8, 21 CFR Part 11, Annex 11, Data Integrity, Risk Approach and Quality by Design.
Solid understanding of Phase I Clinical Trials, and strong knowledge of the regulatory framework around clinical trials
Experience in conducting internal audits for compliance with company procedures and regulatory requirements, hosting customer audits, and knowledge of supplier management.
Excellent written, mentoring, influencing, persuasion and oral communication skills.
Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams.
Strong interpersonal skills with a special focus on customer satisfaction.
Work independently with minimal supervision with the ability to multi-task, work in a fast-paced environment and prioritize work to assure business and compliance objectives are met.
Detail oriented with excellent problem-solving and organizational skills.

Responsibilities

Ensure efficient and effective execution of QA systems in accordance with procedures, policies, work instructions, and regulatory requirements.
Management of the Quality Management System Program through Veeva (Deviations, CAPAs, Chance Control, Document Requests, Document Change Controls, and Audit reports). Management of Protocol deviations and Adverse events for tracking and trending purposes.
Notify document Owners of documents requiring periodic review approximately 3 months in advance of periodic review due date.
Support Key Quality Performance Indicators to drive Operational excellence and problem-solve trends by collection of data and analysis.
Serve as a QA resource to provide input and guidance to cross-function teams on quality issues, Conduct peer review of documentation, as necessary.
Serve as the QA representative to customers, auditors and project teams for early phase support of clinical trials. Actively participate in project meetings.
Perform study audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP), including: Documentation such as clinical protocols and reports Process audits/ inspections
Provide guidance on corrective and preventive actions to address audit findings in collaboration with cross-functional team members.
Develop, implement, and maintain the site’s quality system. Author, review and approve SOPs and assure compliance with current regulatory requirements. Assure documents are issued, controlled, and archived in accordance with company procedures.
Collaborate with Functional Area Manager and Clinical Compliance Training Coordinator to determine job curriculums, SOPs/WI/Policies, OTJ Training and Job-Specific Competencies for each role of the Organization applicable to the Site.
Support Line Managers with GDP Trainings to ensure appropriate Training Material is available
Review of governance documents for compliance with Quotient and Regulatory Requirements, and or Quality Event driven changes.
Ensures that documents are clear, concise and, if the document is an SOP, ensuring it is written in alignment with rules and regulations.
Participate in the change control process to ensure changes to processes, systems, equipment, and facilities are appropriately assessed and implemented after proper verification of changes.
Interpret and provide guidance, coaching, and mentoring to other functions and, where necessary customers on regulatory requirements and expectations.
Participate in the planning and execution of customer audits related to clinical projects.
Provide guidance and feedback during investigations of quality issues. Serve as RCA coach, both in supporting the RCA planning and throughout investigation and CAPA planning.
Assure that root cause(s) are identified, and effective corrective actions are implemented in a timely manner to mitigate the recurrence of issues.
Review Continuous Improvement Proposals (and associated action items) to assess whether the initiative constitutes a change that impacts the GxP status of facilities, systems, processes, personnel, or equipment.
Develop productive, dynamic, professional working relationships founded on trust and respect with project team personnel and customers.
Coach and mentor other QA clinical personnel and assure alignment and consistent decision-making within the team.
Provide GCP training and other training as required for new and existing employees.
Veeva Management
Perform other duties as required.