Technical Director

ManpowerGroup; Curitiba; Presencial; BRL 600 000 - 850 000; Tempo integral

Resumo da oferta

ManpowerGroup is seeking a senior leader to oversee affiliate Quality and Regulatory functions in Curitiba. The role ensures compliance with medicinal product and IVD requirements, effective QMS oversight, and lifecycle management with Health Authorities.

External engagement with Health Authorities and partners is essential. Key duties include governance of QMS, complaint and CAPA processes, supplier oversight, audits, regulatory strategy, and ongoing training.

Qualificações

• Degree in Pharmacy or related scientific field; regulatory requirements apply.
• Advanced degree in pharmaceutical sciences or regulatory affairs preferred.
• Experience in QA, regulatory affairs or technical operations in pharma/med devices.

Responsabilidades

• Provide leadership and governance for QMS and GDP-compliant distribution.
• Oversee complaints, deviations, CAPAs, change controls and QA KPIs.
• Represent affiliate in health authority inspections and regulatory interactions.
• Ensure licenses, permits and authorizations are maintained.
• Drive training and competency programs in Quality and Regulatory areas.

Conhecimentos

Strategic leadership

Stakeholder management

Communication

Risk management

Negotiation

Team development

Formação académica

Pharmacy degree

Advanced degree in Pharmaceutical Sciences or Regulatory Affairs

Ferramentas

Microsoft Office

QMS software

Descrição da oferta de emprego

Provide leadership, governance and accountability for the affiliate Quality and Regulatory functions, ensuring compliance with applicable requirements for medicinal products and IVD medical devices, effective oversight of the Quality Management System, and appropriate management of product lifecycle activities and interactions with Health Authorities.

ENVIRONMENT

Internal interaction with affiliate staff, Business Division teams, Corporate Quality, Regulatory Affairs, Pharmacovigilance, Technovigilance, Supply Chain, Commercial and other relevant Corporate Departments. External interaction with Health Authorities, customers, manufacturers, suppliers, distributors, service providers and other business partners.

TASKS, ACTIVITIES AND RESPONSIBILITIES

• Provide strategic direction, governance and oversight for the affiliate Quality Management System (QMS), ensuring its effectiveness, continuous improvement and compliance with applicable regulations and Corporate requirements.
• Ensure appropriate management, review and escalation of complaints, deviations, CAPAs, change controls and quality risk management activities, and establish effective oversight of Quality Key Performance Indicators (KPIs).
• Provide oversight and, where required, approval of internal and outsourced activities related to receipt, storage, segregation, shipping, transport, returns and destruction, ensuring compliance with applicable Good Distribution Practices and Corporate Quality requirements.
• Represent the affiliate in significant quality matters involving customers and manufacturers, ensuring appropriate investigation, resolution and escalation of quality issues.
• Establish and oversee the affiliate Quality training program, ensuring that personnel are appropriately trained and qualified. Provide expert technical guidance and training when required.
• Govern the supplier qualification and monitoring program, approve service& product providers as applicable, and oversee the planning and outcome of external supplier audits. Lead or participate in critical audits when required.
• Oversee the qualification and periodic review of distributors and assess and approve customers in accordance with applicable quality, regulatory and Corporate requirements.
• Provide the final local Quality and Regulatory assessment and approval for new products proposed for commercialization, ensuring that relevant requirements are integrated throughout the product lifecycle.
• Lead and provide oversight of local product recall activities, ensuring timely decision-making, escalation and communication with relevant stakeholders and Health Authorities.
• Establish and approve the risk-based Internal Audit Program, oversee its execution and ensure that significant findings are appropriately addressed and escalated. Lead or participate in selected audits when required.
• Lead and represent the affiliate during significant external audits and Health Authority inspections, ensuring appropriate preparation, response, follow-up and escalation of critical observations.
• Ensure that all licences, permits and authorizations required for products and import and distribution activities are obtained, maintained and renewed within applicable timelines.
• Provide oversight and approval of local regulatory strategies, dossiers and applications for registration, renewal, variation and lifecycle management of the company’s medicinal products and medical devices.
• Serve as the affiliate’s senior Regulatory and Quality representative before Health Authorities and ensure effective management of significant regulatory interactions.
• Provide final local Regulatory approval of advertising and promotional materials, ensuring compliance with applicable requirements and Corporate standards.
• Hold accountability for the local Pharmacovigilance System in accordance with applicable Brazilian requirements, ensuring appropriate governance, oversight, reporting and escalation of safety matters.
• Hold accountability for the local Technovigilance System in accordance with applicable Brazilian requirements, ensuring appropriate surveillance, reporting, escalation and management of medical device safety matters.
• Promote a culture of quality, regulatory compliance, ethical conduct and patient safety, drive risk-based decision-making, and influence and align cross-functional stakeholders across the affiliate.

ACADEMIC REQUIREMENTS

• Degree in Pharmacy or another scientific discipline, as permitted by applicable Brazilian regulatory requirements.
• Advanced degree or postgraduate qualification in pharmaceutical sciences, Regulatory Affairs, Quality Management or a related field is preferred.

PROFESSIONAL EXPERIENCE

• Significant experience in Quality Assurance, Regulatory Affairs and/or Technical Operations within the pharmaceutical, biotechnology, medical device or healthcare industry.
• Demonstrated experience in the governance of Quality Management Systems and GDP-compliant distribution activities.
• Proven leadership experience in a regulated environment, including cross-functional stakeholder management and risk-based decision-making.
• Experience interacting with Health Authorities and leading or supporting regulatory inspections and external audits.
• Experience with medicinal products and medical device regulatory lifecycle activities.

Advanced user of Microsoft Office and proficient in the use of electronic Quality and Regulatory systems.

LANGUAGES

Portuguese (native or full professional proficiency)

SKILLS (Personal capabilities)

• Strategic leadership and sound decision-making.
• Strong accountability, integrity and independent professional judgement.
• Ability to represent the affiliate effectively before Health Authorities and external stakeholders.
• Strong stakeholder management, influencing, communication and negotiation skills.
• Quality and regulatory risk management, problem-solving and continuous improvement capabilities.
• Ability to lead, develop and empower teams and to operate effectively in a complex, cross-functional and regulated environment.
• Business acumen, organizational effectiveness and ability to manage competing priorities.