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

Job Description

Job Description

Join us as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality!

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.

Abeona Therapeutics Inc.: Who We Are

Our Values: Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Your day-to-day as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality

As a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality at Abeona Therapeutics, your day-to-day activities will focus on 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. The role will control document lifecycle activities, perform verification and auditing of data generated during clinical/non-clinical studies, develop and lead quality oversight programs, ensure compliance with the FDA, EMA, and ICH, coordinate CGP/GLP audits, and will play a key role in coordinating information and guidance for internal and external stakeholders to ensure compliance with relevant standards and regulations.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Schedule

The usual working hours for this role are Monday to Friday (some late or weekend work may be required) during the first shift, from 9:00 – 5:00 (start and end times may vary) (with some late night or weekend work on occasion).

Does this sound like you?

To thrive as a Sr. Manager, Quality Assurance, Clinical/Non-Clinical Quality, the right combination of experience, education, skills, and attitude is essential.

This role requires a high level of independent expertise and practical experience with the review of clinical study data, SAS datasets, clinical study reports, case report forms, and data listings in the biopharmaceutical or pharmaceutical space. The ability to communicate as an SME to internal staff of various backgrounds, as well as external CRO and regulatory bodies is essential to being successful in this position. Do you enjoy planning ahead, developing SOPs, interpreting and improving existing processes, and working to keep everything compliant within a regulated environment? This could be a good fit for you.

Strong preference will be given to candidates that are willing to work on-site in our Cleveland, Ohio facilities.

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 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

Required Qualifications & Competencies

The knowledge and skills required to be successful in the role are:

• 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.
• Strong preference for candidates who possess 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.

Preferred Qualifications

• 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

Competencies:

• 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.

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 accommodation 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 work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is required. May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.

Connect with our team today!

If you're ready to take your career to the next level and join a team that values hard work and changing lives - complete our application today!