Senior Director Quality Assurance Operations Join to apply for the Senior Director Quality Assurance Operations role at Recordati Rare Diseases North America

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below. Senior Director Quality Assurance Operations Join to apply for the Senior Director Quality Assurance Operations role at Recordati Rare Diseases North America Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Recordati Rare Diseases North America With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life. 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. 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: Ensuring robust documentation practices and data integrity Overseeing the preparation and quality review of regulatory submissions, ensuring that quality components reflect sound science, risk-based thinking, and transparent justification of decisions 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: Product Technical Transfer 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 GMP, GCP, GDP knowledge Project management Managing People Networking and collaborating 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. At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential. We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today. Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Recordati Rare Diseases North America by 2x Sign in to set job alerts for “Director of Quality Assurance” roles. 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