Job Details
Posted 14 May, 2026
Job Id: 627986
Quality Assurance Specialist I
Job Description
Technical Job Responsibilities
- Manage required quality activities in the Clinical and Commercial PT distribution and in-country GMP/GDP operations owned by PT, including as applicable:
- Regulatory readiness activities required to ensure a regulatory compliant supply of clinical and commercial material, such as the quality oversight of Artworks operations; management of GMP documents required for Launches, Variations & Renewals and management of IMP Flowcharts required to ensure compliance to the respective IND/QIMPD.
- Quality oversight of Transportation activities including the management, resolution and Product Quality impact assessment of unplanned and planned events during transportation of clinical an commercial products.
- Quality oversight of Clinical and Commercial PT distribution and in-country GMP/GDP operations, taking place at Transport providers; Warehousing & distribution centers; Partners (including External Sponsors of Clinical Trials, In- / Out-Licensing Partners, Divestment Partners and Co-Promotion Partners); Local CMOs and Laboratories contracted for in-country testing activities.
- Customer engagement activities, including the intake and response to Customer complaints and the design and deployment of Customer-centric solutions applicable in the distribution operations
- Own, manage and build Quality capabilities within the Distribution Quality Chapter and the
- Country Quality Network to meet Strategic Objectives, Customers expectations and promote a value-driven mindset.
- Identify and drive continuous improvements by actively scanning and keeping up to date on customers needs and expectations, regulatory requirements and industry trends and network performance results.
- Ensure Audit and inspection readiness in the Clinical and Commercial PT distribution and in country GMP/GDP operations
- Own, manage and drive the implementation of Quality requirements applicable to Distribution in defined within PQS, and collaborate with external stakeholders to shape and evolve the corresponding regulatory requirements
- Release, reject or quarantine clinical/IMP, commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within
- the area of responsibility per applicable Swissmedic and internal requirements on behalf of the Authorized Person (AP).
- Disposition (release or reject) product within the area of responsibility per applicable Roche requirements, cGMP, and the schedule. Support QP Declaration and Certification requirements.
Pay Rate Range: $30-40/hr depending on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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