Senior Director Quality Assurance Operations

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 rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To:     Group Quality Head & Vice President
Direct Reports:    None
Areas Managed:    Global Program Quality, Rare Diseases

Overview

Senior Director Quality Assurance Operations will be responsible for developing and leading the global QA strategy and operations for the RD Business Unit (current and upcoming products). This role ensures that all products meet regulatory requirements, corporate quality standards, and industry best practices, acting as the quality steward across the entire portfolio. He/She will collaborate internally cross-functionally with R&D, Regulatory Affairs, Manufacturing, and Commercial teams and externally CMOs to support the company’s commitment to delivering safe and effective therapies to patients. This is a global leadership role with oversight of teams across multiple geographies.

Essential Duties and Responsibilities

QA Strategy RRD
•    Develop the QA RRD products strategy across clinical, manufacturing and commercial product lifecycle 
•    Ensure end-to-end quality oversight and implementation of the quality system
Process Compliance
•    Ensure adherence to international standards and internal SOPs across all QA-RRD related processes
•    Promote a culture of compliance by embedding quality principles into day-to-day operations,
•    proactively identifying process gaps, and leading cross-functional remediation efforts
•    Enhance process robustness across clinical, manufacturing, and distribution activities to minimize compliance risks and Regulatory Compliance
Manufacturing Quality
•    Partner with internal and external manufacturing partners (CMOs) to ensure product quality, batch release and deviation Management
Management of Health Authority Inspections
•    Act as primary QA liaison with regulatory authorities, leading the preparation for inspections, hosting audits, and managing follow-up actions with a strategic mindset. This includes:
o    Ensuring robust documentation practices and data integrity
o    Overseeing the preparation and quality review of regulatory submissions, ensuring that quality components reflect sound science, risk-based thinking, and transparent justification of decisions
o    Given the high cost and ethical sensitivity of rare disease therapies, this role must anticipate regulator concerns not only regarding product safety and efficacy but also manufacturing scalability, cold chain integrity, product traceability, and long-term follow-up
QA GMP
•    Coordinate GMP within CMOs and act as a main point of contact
QA GDP
•    Coordinate activities of QA functions of RD commercial affiliates to ensure they operate in compliance with applicable GDP
•    Strategic Relationship and Quality Integration

•    Act as the primary Quality point of contact for strategic business directions in partnership with Commercial, Regulatory Affairs, Product Supply and BD
•    Serves as primary Quality point of contact for: 
o    Product Technical Transfer
o    QMS integration of new products from M&A, in licensing agreements and R&D
•    Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
•    Perform other duties as may be assigned

Education and Experience

•    Degree in Life Sciences, Pharmacy, or a related field
•    Minimum 15 years of experience in the pharmaceutical/biotech industry with at least 7 years in a senior QA leadership role
•    Demonstrated experience in rare diseases or orphan drugs, ideally in both development and commercial settings
•    Experience managing external partners (CMOs)
•    Working experience in international contexts, preferrable global ones
•    Proven ability to operate in a matrix environment

Knowledge and Skills

•    Strategic thinking & global perspective
•    Resilience & adaptability
•    Proactivity in change 
•    Influencing & negotiating 
•    GMP, GCP, GDP knowledge
•    Project management    
•    Managing People 
•    Networking and collaborating

Work Environment

This job operates in a professional office environment. Based upon job requirements, employee may be required at times to attend meetings including travel out of province over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employees are required to have a valid driver’s license and passport.

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 a commercial air carrier.  This is largely a sedentary role when working in office; 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 required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    This position is located at RRD HQ Office in Bridgewater, New Jersey with 3 days per week in the office as minimum expected.  
•    The position requires domestic and international travel (up to 50%)

FLSA Classification

•    This position is considered Exempt.

EEO Statement

Recordati Rare Diseases values the diversity of its workforce and welcomes applications from all qualified applicants. 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, provincial, or municipal law.  Recordati Rare Diseases will provide reasonable accommodation for qualified individuals 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.

Disclosures

Hourly Pay Range (Base Pay): $235,000 - $255,000 Other Types of Pay: Annual bonus Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long term disability insurance benefits. Retirement Benefits: 401k Paid Time Off: Vacation, holiday, and sick/personal time.