Senior Manager, Quality Assurance - Clinical/Non-Clinical Quality

Abeona Therapeutics•Cleveland, OH

6d•Hybrid

About The Position

Join Abeona Therapeutics as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies. Work onsite (remote may be considered for the right candidate) Monday to Friday (some late or weekend work may be required) from 9:00 to 5:00 (start and end times may vary) and contribute to impactful products that change people's lives. With a competitive salary of $110,000 to $132,000 per year (plus annual discretionary bonus and equity opportunity), this position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment. You will have options to participate in a comprehensive benefits program that includes options for medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year. Oh, and snacks! We have healthy snacks and beverages, as well as a few good, old-fashioned sweets, so that you can keep those energy levels up throughout the day.

Requirements

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.
Must possess professionalism and ability to effectively interact and communicate with internal staff and management as well as with external CRO and regulatory bodies.
Can operate independently and be able to identify observations and/or gaps in 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.

Nice To Haves

Strong preference for candidates who possess CCRP, ACRP, CPMA or equivalent certification.
Experience supporting IND, BLA, or NDA programs
Lead Auditor certification (ASQ CQA, ISO 19011, or equivalent)
CCRP, ACRP, CPMA or equivalent certification.
Experience with computerized systems validation and data integrity assessments
Experience leading or supporting FDA Bioresearch Monitoring (BIMO) inspections and regulatory agency interactions
Strong preference will be given to candidates that are willing to work on-site in our Cleveland, Ohio facilities.

Responsibilities

Control document lifecycle activities, including biennial review of procedures and document retention.
Performs verification and auditing of data generated during the conduct of clinical/non-clinical studies ensuring compliance with standard operating procedures and regulatory requirements.
Lead 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.
Develop and maintain a risk-based Vendor Quality Management Program, including vendor qualification, quality agreements, performance metrics, periodic audits, and ongoing oversight of CROs and other GxP service providers supporting clinical and nonclinical development activities.
Evaluation and review of clinical trial deviations to ensure appropriate investigation has been conducted, documented and corrective measures implemented to prevent future occurrences.
Lead GCP/GLP-related inspections by Regulatory Authorities, including pre-inspection activities and BIMO inspections.
Own 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 Operations/Development, Medical Affairs, and Research and Development Teams as well as external vendors/CROs.
Travel up to 30%, both domestic and internationally, including audits and regulatory inspection support.
Perform other duties as required