Local Safety Officer / Affiliate Quality Responsible

Job description

  Job facts

The Head of Quality is responsible for ensuring that all Good Practices and regulations impacting Roche Diagnostics Baltics activities are delivered to the Roche standard of quality and drives compliance in accordance with the applicable regulatory requirements, the Roche Quality Management System, policies and written procedures and industry best practices.

Key accountabilities:

·  Serves as primary Affiliate contact for Safety Board matters.
·  Responsible for prompt execution of, and communications related to, Safety Board decisions, pursuant to Safety Board instructions.
·  Serves as primary contact for local regulatory authorities related to complaints, recalls and/or corrective field actions. Promptly informs relevant Safety Board Chair and/or Business Area (BA)/Business Unit (BU)/Global Platforms and Support (GPS) of any such contact.
·  Responsible for the development and implementation of local processes to capture, document, and manage inquiries, complaints, and logistics claims in a timely manner.
·  Provides training on complaint handling to employees as required to comply with applicable regulations and Roche Diagnostics processes.
·  Enforces correct and accurate use of the IT system(s) used for complaint case management.
·  Ensures that any third-parties involved in the complaint handling process are governed by a suitable written agreement.
·  Leads and manages the strategic and operational performance of the Quality Management System at the affiliate level, ensuring the successful delivery of the Global Quality Strategy, whilst maintaining oversight and adherence to local regulatory requirements.
·  Adopts and implements local processes in accordance with the applicable Divisional Standards
·  Promotes a quality culture that ensures the highest standards of Quality Compliance.
·  Proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance.
·  Acts as applicant and owner of the regulatory submissions process.
·  Acts as primary contact for the local Regulatory Authority regarding registration of products distributed by Roche Diagnostics in the country.
·  Provides timely feedback to the Global Regulatory functions on changes to local regulatory requirements.
·  Ensure compliance with Roche and Local promotional requirements and Regulatory Divisional Standards.

Requirements:

·  Bachelor degree in Natural/Life science field; advanced degree and/or certification preferred.
·  Knowledge of local regulatory requirements
·  Fluency in English
·  More than 3 years of experience in a biopharmaceutical company or equivalent.
·  Quality Management experience is desirable
·  Inspiring and Influencing: an ability to influence, act as a change agent, build consensus and manage conflict in challenging situations.
·  Technical expertise
·  Teamwork and Collaboration: good stakeholder management and the ability to effectively collaborate across a global organization.
·  Communication: strong verbal and written communication skills. Excellent listening and decision making skills.
·  Well-organized, detail oriented professional, ability to prioritize and make decisions.
·  Highly self-motivated; able to lead initiatives with authority.

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.