Contractor Senior Manager, Quality Responsible, Mexico

Why Join Us? Be a hero for our rare disease patients. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. Position Summary ultra innovative - Tackle rare and dynamic challenges The México Senior Manager Quality Responsible "Responsible Sanitario" is a member of the Quality Assurance Operation Department with responsibilities to support the development, implementation, and maintenance of the México Quality System where Ultragenyx has approved products and to ensure the local Quality systems are in compliance with regulations and local requirements and are always audit and inspection ready. This position will be responsible to promote, maintain, improve compliance and drive the changes required to comply with regional regulatory requirements and Good Manufacturing and Good Distribution Practices (GMP / GDP) as well as presenting excellent understanding, quality mindset and proven experience in GMP / GDP in Mexico and with working knowledge of regional regulations, initiatives, standards and GMP / GDP practices. The role will be appointed to fulfill the Sanitario Responsible (SR) roles in México before COFEPRIS. This role must maintain excellent relationships with all stakeholders, vendors, license partners and other third parties internal and external to Ultragenyx, excellent written and verbal communication skills, as well as hands‑on Quality experience with a proven track record of major accomplishments. The México Senior Manager Quality Responsible "Responsible Sanitario" will report directly to Head of Quality Assurance EMEA (Ultragenyx Netherlands) and be supported by the Quality Department delegates. For local activities in Mexico, this role will report to and be supported by General Manager Ultragenyx Mexico. Work Model Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities Quality Responsible person to represent Ultragenyx to the national health authorities in Mexico COFEPRIS. Responsible for the release of the Ultragenyx medicinal products to the market in compliance with local regulations. Coordinate and supervise the elaboration, administration, training and maintenance of the documents of the Quality Management System, as well as quality activities such as product complaints, deviations, CAPA, change control, annual product Quality Review, product market release and analysis as well as the updating of the quality management system for the operation of the company according to local regulations and in compliance with policies and procedures of the organization. Develop and maintain product quality process (Standard Operation Procedures (SOPs), Manual or other), as well as address product complaint reports. Oversee the administration and upkeep of Quality Agreements, ensuring alignment with regulatory requirements, operational standards, and organizational objectives. Supervise the process for sampling retention samples of Ultragenyx commercial products in the warehouse according to local regulations even when local analysis is not required. Ensure that the artworks of the product comply with local regulations. Lead / supervise analytical transfers and local approval of final reports. The Qualified Person verifies the quality of the product and approves its release into the market. Supervise and assure any Drug Stability Studies are carried out for the products of the company, comply with the regulations and approved protocol. Develop and set up of programs for quality compliance such as transport and others involved in distribution activities based on global procedures. Ability to assess and mitigate risks in manufacturing, storage, and distribution processes. Supports and performs delegated tasks on behalf of the Marketing Authorisation Holder (Ultragenyx Netherlands BV). If required, a third party may process supervise, inspect, and release the product. Submission of the notification to the health authorities and assure the supplier's compliance and generation of documentation. Perform internal audits and audits of suppliers, as required (warehouse, analytical, transport, third parties, etc.) as well as #J-18808-Ljbffr