Director, Quality Assurance

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Vice President, North American Regulatory Affairs and Quality Assurance
Direct Report(s): Quality Systems Administrator
Areas Managed: Quality Assurance
 

Overview

The Quality Affairs Director will be responsible for leading the North American GxP compliance efforts across non-production (non-Good Manufacturing Practice/Good Distribution Practice)  related areas, including clinical trials, regulatory submissions, and clinical operations. The successful candidate will oversee the development, implementation, and maintenance of quality systems to ensure adherence to industry regulations and company policies. This role requires a dynamic leader with a deep understanding of GxP standards and a proven track record in quality assurance within the pharmaceutical or biotech industry. This position will lead the implementation of Quality processes and Inspection Readiness Activities, assist with the management of the audit program and partner with key cross-functional groups (e.g., Clinical Operations, Regulatory, Biometrics, Pharmacovigilance) to ensure compliance of RRD’s activities for continuous process improvement.

Essential Duties and Responsibilities

•    Develop and implement GxP compliance oversight and compliance management across the North American business unit ensuring adherence to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Documentation Practice (GDP) and Good Pharmacovigilance Practice (GVP) standards. 
•    Oversee the implementation, maintenance and improvements of the North American quality management system (QMS) to ensure regulatory compliance.
•    Manage the development, review, implementation and training of quality standards and controlled documents (e.g. SOPs, work instructions, templates) 
•    Within the QMS program lead and manage quality systems that include audits (both internal and with external partners) inspections, CAPAs (Corrective and Preventive Actions) and change control process.  
•    Ensure quality metrics are tracked, analyzed and reported to senior management. 
•    Promote compliance and quality throughout the company and represent the Quality in internal and external discussions/meetings
•    Plan, conduct, report and follow-up on quality audits within regulated areas of scope and associated follow-up activities (e.g. reports, corrective actions)
•    Develop and maintain the audit strategies in collaboration with the Team 
•    Deliver quality advisory expertise both internally within the company and to external vendors/partners
•    Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider qualification and assist with site and issue management
•    Manage a “constant” inspection readiness program (e.g. project management for inspection readiness, preparation of team-members/clinical sites/service providers)
•    Other duties, as assigned
 

Education & Experience

•    Bachelor’s degree in Life Sciences (higher degree, preferred)
•    10+ years of relevant GxP pharmaceutical industry and clinical research and development experience 
•    5+ Quality Assurance auditing 
•    Proficiency in the use of a quality system (preferably Veeva) 
•    Experience with due diligence process and qualification of new vendors/service providers 
 

Knowledge and Skills

•    Working knowledge of applicable laws, regulations, and guidance related to GxP
•    Experience leading, developing and/or implementing inspection readiness program and associated activities
•    Experience in managing inspections and post-inspection follow-up activities
•    Proficient with Microsoft based applications and ability to learn internal/external applications/systems 
•    Ability to identify quality issues/discrepancies, and effectively and proactively manage, and resolve the issues/discrepancies in a diplomatic, flexible, collaborative, and constructive manner
•    Strong interpersonal, organizational, communication (verbal/written) skills, organizational skills and attention to detail
 

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.  Based upon job requirements, employee will be required at times to attend meetings including travel out of state over weekends and nights.  Employee must be able to freely operate and travel by car and train/plane modes of transportation.  Employee is required to have a valid driver’s license and passport and means of transportation.

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. The employee must be able to fly via commercial air carrier.  This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    This is an in-office position, based at RRD’s Headquarters in New Jersey 
•    20-40% travel required (domestically and/or internationally)
 

FLSA Classification

This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin.  Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law.  Recordati Rare Diseases will provide reasonable accommodation for qualified individual with disabilities.  

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.