Technical Quality Director (pharmaceutical)
Job Title: Technical Director
Location: Colonia del Sacramento, Uruguay (on-site modality) Contract Type: Service invoicing
About the position
At SGF Global, we are looking for a Technical Director to join Flextem Biopharma, a Uruguayan company dedicated to medicinal cannabis, with export operations to Europe and Brazil.
The selected person will assume the Technical Direction and leadership of the company's quality line. They will have a key role in strengthening the management system, monitoring regulatory bodies, and complying with the standards required by international markets.
We are looking for a profile with solid knowledge of quality, especially in process validation and equipment qualification, characterized by autonomy, proactivity, and the ability to provide constant follow-up to multiple processes.
Main responsibilities
- Assume the Technical Direction and regulatory supervision of the company's operations.
- Lead and strengthen the quality management system.
- Coordinate the formation and development of the quality team.
- Guarantee compliance with regulations and standards applicable to the pharmaceutical and medicinal cannabis industry.
- Lead the validation of processes and the qualification of facilities, equipment, and systems.
- Supervise change control processes, risk management, deviations, corrective, and preventive actions.
- Perform follow-up on procedures, registrations, licenses, and authorizations before the Ministerio de Salud Pública and other organisms.
- Maintain active and constant interaction with regulatory authorities to ensure the progress of processes.
- Coordinate and attend audits from clients, certifying bodies, and national and international authorities.
- Guarantee compliance with GMP, GACP, GDP, ISO standards, and other applicable regulations.
- Provide technical and regulatory support to export processes to Europe, Brazil, and other markets.
- Prepare, review, and respond to technical documentation, audit reports, and communications in English.
- Represent the company before regulatory authorities, strategic partners, and international organizations.
Requirements
- University degree in Química Farmacéutica, Farmacia, Química, Bioquímica, Biotecnología, Ingeniería Química, or related fields, provided that the training and professional licensing allow for assuming the responsibilities of the position.
- Minimum of five years of experience in positions linked to Technical Direction, quality assurance, quality control, or regulatory affairs.
- Solid experience in quality management systems.
- Verifiable knowledge of process validation and equipment qualification.
- Experience in the follow-up of procedures and processes before regulatory authorities.
- Knowledge of regulations and standards such as GMP, GACP, GDP, and ISO.
- Availability to work on-site and reside in Colonia del Sacramento.
- Ability to read technical documentation, interpret reports, and respond to communications in English.
Especially valued
- Training as a Químico/a Farmacéutico/a.
- Experience in the medicinal cannabis industry.
- Experience in interaction with international regulatory authorities.
- Participation in international audits.
- Experience in import and export processes of regulated products.
- Fluent oral English.
- Knowledge of Portuguese.
Who Are We?
Talent where you need it, when you need it!
SGF Global is a leading provider of specialized talent solutions, dedicated to connecting highly qualified professionals with opportunities in multiple sectors. We offer temporary, permanent, and project-based hiring solutions in areas such as technology, finance and accounting, engineering, marketing, legal services, administrative and customer support, energy, oil and gas, telecommunications, manufacturing, aerospace, life sciences, mining, and utilities.
At SGF Global, we work to position you in the best place to succeed. We give you access to high-level opportunities, competitive compensation, attractive benefits, and free online training. Stay on top of every opportunity, at all times, even from your cell phone.
-Requirements- Minimum education: University years of experience Languages: English, Portuguese Keywords: lider, jefe, gerente, manager, director, chief, lead, jefatura, regente, tecnologo, tecnico, tech, technician, technology, tecnologia, technologist, quality, qa