Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    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:

ultrainnovative – 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. This includes regular reviews, updates, and effective communication with stakeholders to maintain compliance and foster collaboration 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., if applicable. 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 regarding quality concerning the sanitary regulations. Provide the report and/or recommendations corresponding to the results of the carried-out audits to the different warehouses. Requirements: Pharmaceutical Chemist Biologist (QFB), Pharmaceutical Industrial Chemist (QFI), or a healthcare professional related to pharmacy, residing in Mexico, with a university degree and a professional license (i.e., third-level qualification). A postgraduate degree in Quality, or Administration is highly desirable, although other relevant experience will also be considered. Candidates must have a valid official identification, FIEL (digital certificate, private key, and password), and a current proof of tax situation (issued within the last 3 months). The Sanitary Responsible must have the necessary academic background, knowledge, and experience, with a minimum of 3 years of experience as a Sanitary Responsible, to make informed decisions. Proven knowledge and experience in handling the General Health Law, the Regulation of Health Supplies, NOM-059-SSA1-2015 Good Manufacturing Practices for Medications, NOM-073-SSA1-2015 Stability of Drugs and Medications, NOM-072-SSA1-2012 Labeling of Medications, NOM-220-SSA1-2024 Installation and Operation of Pharmacovigilance, Mexican Pharmacopeia (FEUM) and its Supplement for Establishments Dedicated to the Sale and Supply of Medications and Other Health Supplies. Ability to navigate fast paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must. Experience working in innovative and groundbreaking therapies with demonstrated track record of accomplishments with high visibility programs preferred. Demonstrated success in initiating and managing partnerships with external vendors and business partners. Excellent oral and written communication skills in English (required) and Spanish (required). High ethical standards, including a commitment to Ultragenyx values and behaviors. Working knowledge of industry standard quality databases (eg Veeva Vault), Regulatory databases, and other electronic data capture systems. Computer literacy with proficiency in Microsoft Excel, PowerPoint and Word. Willingness to be onsite as needed; some national/international travel may be required; willingness to travel including overnight trips. #LI

 

#LI-CT1, #LI-Hybrid

  Full Time employees across the globe enjoy a range of benefits, including, but not limited to:   ·         Generous vacation time and public holidays observed by the company ·         Volunteer days ·         Long term incentive and Employee stock purchase plans or equivalent offerings ·         Employee wellbeing benefits ·         Fitness reimbursement ·         Tuition sponsoring ·         Professional development plans   * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.