Global Regulatory Affairs Quality Process Manager

Chiesi
United States, North Carolina, Cary
175 Regency Woods Place (Show on map)
Mar 07, 2025
*About us* Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. *Chiesi USA* Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work. *What we offer* Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi." *Who we are looking for* Purpose Ensure adequate compliance and management to the Global Regulatory Affairs quality system according to internal and external requirements (i.e., Health Authorities). The candidate should be committed to working our hybrid model from the Cary, NC office. Main Responsibilities GRA Quality documentation (Manual, SOP, WI and best practices) related activities Be the GRA point of contact for Quality documentation, including questions related to their creation and maintenance Participate in the review of the GRA Quality documentation to verify the compliance to templates, standard terms and fit in the GRA overall quality system Coordinate the Regulatory related cGMP documentation within the electronic document management system. Monitor for timely periodic reviews, training completion, perform quality checks and rendering documents effective With the support of the GRA Quality documentation authors as necessary: maintain the list of the available GRA Quality documentation and associated electronic-learning (e-learning) materials define the GRA Quality documentation annual planning revision and oversee its completion to ensure the documents are up-to-date and in line with current practises lead impact assessment of transversal projects or re-organisation on the GRA Quality documentation and oversee the revision plan Create and maintain overall GRA Quality documentation process mapping Department Training Administrator (DTA) activities With the support of line managers: oversee GXP training records for GRA and external GRA's consultants including, maintaining professional figures, assigning training in e-learning management system, registering internal training data for GRA personnel, ensuring training is completed in a timely manner and pulling training records/reports oversee onboarding activities for new GRA personnel as far as training activities are concerned Be the point of contact for GRA Quality documentation authors to plan and organise appropriately the in-person trainings as necessary Support the GRA Quality documentation authors in the creation and maintenance of e-learning materials Be the QA point of contact within GRA for all topics related to training (e.g. compilation of R&D training programme, maintenance of the e-learning management system, training compliance etc.) Archivist activities: Ensure maintenance and archival of records, paper and electronic, in accordance with internal procedures to maintain complete Regulatory files for each product Oversee and maintain the internal procedures related to storage of regulatory files Maintain US on-site document storage room Manage US off-site storage vendor and track documents sent and received Quality Control review of U.S. regulatory submissions and internal documents Serve as Archivist in coordination with corporate partners for Clinical documentation Support to GxP data extraction activities: Perform extractions from RIMS for GPV purposes. Ensure extraction, elaboration, and quality check of product registrations worldwide or KPIs (e.g. related to safety variations submission) from RIMS to be included in the Pharmacovigilance System Master File Experience Required 4 years in Scientific related area with experience in Regulatory and/or Quality preferred Communication Ability to multi-task Attention to detail High Productivity Understanding of pharmaceutical regulations and processes Good knowledge of process analysis and optimization methods and tools Make effective decisions Plan and execute effectively Drive results Education Bachelor's Degree in Life Sciences- required Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.