Specialist Quality Complaints

About Avadel Pharmaceuticals plc

Who We Are: Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Oxybate therapy is currently the standard of care for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients living with narcolepsy. However, currently approved oxybate products are immediate release formulations requiring two nightly doses - one dose at bedtime and the second dose 2.5-4 hours later, in the middle of the night. Our current lead drug candidate, LUMRYZTM (sodium oxybate) extended release for oral suspension (formerly known as FT218), applies our proprietary drug delivery technology to allow for a single bedtime dose, eliminating the need to have a forced awakening during the middle of the night and giving patients the chance for an uninterrupted night's sleep. An extended-release medication sounds like a simple innovation, but it is what has been lacking for 20 years, and we believe this will be transformative for people with narcolepsy. For more information, please visit www.avadel.com or check out narcolepsydisrupts.com.

What We Do: LUMRYZ has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that LUMRYZ may be clinically superior to a formulation of sodium oxybate already approved by the FDA for the same indication.

The FDA granted a tentative approval to LUMRYZ on July 18, 2022. Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. FDA's final approval decision for LUMRYZ is pending expiration or other disposition of a patent listed in FDA's Orange Book that expires on June 17, 2023. Avadel's market research suggests that LUMRYZ has the potential to command a meaningful share of the multi-billion-dollar narcolepsy treatment market.

We are currently taking steps to accelerate the final approval of LUMRYZ earlier than the expiry of the patent in June 2023, however, in either case, we are gearing up for our full launch now. We can't wait to bring an innovative new treatment option to the narcolepsy community.

How We Work: At Avadel, patients are the reason we exist, and our employees are our greatest competitive advantage - our "secret sauce." The way we work is as important as the results we achieve. Our employees work together as ONE team and live our Values, which is what makes working at Avadel so special and why we will win for patients. Our ONE Team approach fosters a culture based on being relentless for patients, having confidence with humility, being courageous, taking insights to impact, and togetherness. In everything we do, we live the Avadel Values so we can be our best for our patients, our community and each other.

We are seeking team members who have a passion for making a meaningful impact in the lives of patients. We need individuals who will dive in, roll up their sleeves, and join us in our mission to launch LUMRYZ for the narcolepsy community and be part of building and shaping an exciting future together.

Position Summary:

This position requires strong communication/customer service skills since this position deals with customers on a daily basis. This position requires a strong level of organizational and multi-tasking skill to handle a high volume within the department. In addition, it is required to have an analytical mind to be able to perform complaint investigations and summarize the same for communication to the customer. Required to work independently and efficiently since the department requires meeting strict timelines.

Essential Functions:

• Knowledge of patient use and manufacturing processes for distributed products.

• Ensure Product Quality Complaint system and procedures are compliant with regulatory requirements, industry standard, and Avadel guidance.

• Manage receipt, investigation and closure of product complaints to ensure adherence to established timelines.

• Investigate complaints and document according to Avadel templates and procedures.

• Work with and manage third-party Contract Manufacturers as necessary for applicable investigation activities and/or testing.

• Identify root cause of the complaint and facilitate identification and implementation of corrective and preventive actions as appropriate.

• Perform follow-up communication with the customer/reporter to acquire information that may be required to effectively investigate the customer complaint.

• Support internal and external cGMP audits and regulatory agency inspections and completion of inspection commitments.

• Assist in the handling and processing of field alert reports to FDA as deemed necessary.

• Support operations and quality management initiatives and objectives.

Experience and Qualifications:

• Bachelor's Degree in science or a Pharmaceutical-related field with a minimum of four years experience

• Knowledge and understanding of regulatory compliance / cGMP requirements for pharmaceutical manufacturing processes / operations.

• Demonstrated experience and skills in conducting and documenting quality investigations related to pharmaceutical manufacturing processes.

Competencies and Behaviors:

• Commitment to quality and customer service.

• Demonstrated critical thinking and ability to pay close attention to detail and accuracy.

• Organizational skills with the ability to react to changing deadlines and priorities.

• Strong verbal and written communication skills.

• Manage workload to ensure customer complaint processing stages are completed within targeted turnaround time.

• Ability to use computerized systems to run queries and reports.

• Comfortable addressing complex issues/concerns and escalating to management when necessary.

• Self-Motivated and enthusiastic.

• Ability to consistently exhibit Avadel's Core Values in interactions with peers and customers.

• Ability to handle discrete and/or confidential information.

• Ability to work independently and as part of a team.

• Ability to maintain high ethical standards of integrity and quality.

• Capable of being innovative and dynamic in approach to work.

Avadel is committed to facilitating an open, honest, inclusive, transparent, and productive work environment where we work together as ONE team and ONE culture to be our best for patients, customers, and each other. Avadel is committed to equal employment opportunities and non-discrimination in employment. We believe that all employees and applicants should be treated with courtesy, dignity, and respect. Avadel does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, marital status, ancestry, gender, gender identity, pregnancy, status as a covered veteran, or any other characteristic protected by federal, state, and/or local law. It is our intent to comply with federal, state, and local laws, regulations, and guidelines in our employment practices and in our service to our clients. This policy applies to all terms and conditions of employment including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.