| DESCRIPTION |
| Position Overview |
| The Sr. Manager, Clinical / Non-Clinical Qualityis responsible for executing and supporting quality programs and oversight of daily quality assurance activities supporting clinical operations and non-clinical studies. This person will work with cross functional team members of Abeona. |
| Essential Duties and Responsibilities |
- Control document lifecycle activities, including biennial review of procedures and document retention.
- Performs verification and auditing of data generated during the conduct of a clinical/non-clinical study ensuring compliance with standard operating procedures and regulatory requirements.
- Assist with the development and implementation of a Clinical and Non-Clinical Quality Oversight program to include clear processes and procedures for executing appropriate quality support during clinical trials.
- Assist with providing FDA, EMA, and ICH guidance to support project teams in maintaining compliance and awareness in preparation for agency inspections
- Develop audit schedules and conduct/coordinate global GCP/GLP audits including Part 11, Clinical and Pre-Clinical Data Management/Stats, clinical and non-clinical trial audits.
- Evaluation and review of clinical trial deviations to ensure appropriate investigation has been conducted, documented and corrective measures implemented to prevent future occurrences.
- Support coordination and management of GCP/GLP-related inspections by Regulatory Authorities, including pre-inspection activities and BIMO inspections. Participate in the preparation of responses to external regulatory inspections.
- Review and approve clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations.
- Review non-clinical protocols and drafted reports for compliance to GLP regulatory requirements.
- Provide guidance and expertise on GCP/GLP regulations to internal stakeholders as needed.
- Drive the implementation of integrated and comprehensive data-driven Quality Assurance activities, procedures and policies to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
- Drive implementation of Quality by Design into existing and new clinical processes.
- Summarize Quality activities, trends and areas of potential risk to Leadership and Clinical Team(s).
- Actively participate and collaborate with Clinical Teams.
- Travel up to 30%, both domestic and internationally
- Perform other duties as required.
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| Qualifications |
- Bachelor’s degree in Biological Science or related field.
- Minimum of seven (7) years' experience in Biotechnology, Pharmaceutical or CRO (must have been part of Quality, Compliance, or Regulatory department).
- Five (5) or more years related experience of Quality review of clinical study data, including experience with reviewing SAS datasets, clinical study reports (CSR), Case Report Forms (CRF) and data listings in the biopharmaceutical or pharmaceutical industry.
- Preference to CCRP, ACRP, CPMA or equivalent certification.
- Must possess professionalism and ability to effectively interact and communicate with internal staff and management as well as with external CRO and regulatory bodies.
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| Competencies |
- Can operate independently and able to identify observations and/or gaps in clinically relevant areas.
- Will support highly complex and unique issues where analysis of situations or data requires an evaluation of intangibles. Strong ability to compose clear and concise communications with an astute attention to detail.
- Excellent organizational skills, attention to detail, and Good Documentation Practices.
- Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
- Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
- Comfortable in a fast-paced, patient-focused environment with minimal direction and able to adjust workload based on changing priorities.
- Able to learn new computer systems / programs quickly.
- Strong ability to interpret technical procedures, SOPs, and regulatory regulations.
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| Physical Demands |
| The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required. |