Director, Commercial Affiliate QA Gmp Gdp and

vor 1 Woche

Basel, Basel-Stadt, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

About Idorsia Pharmaceuticals Ltd


Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options.

Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.


Responsibilities:


Director, Commercial Affiliate QA(GMP/GDP) and Qualified Person is a strategic role to achieve enhanced Quality and Regulatory (GMP/GDP) Compliance within EU Idorsia affiliates by developing and implementing a standardized QMS across EU affiliates aligned with HQ QA requirements and ensuring adherence to GMP and GDP requirements for the Idorsia products within the Supply Chain.

Experience as a Qualified Person, preferably in Germany, and PV QA experience is a plus.

  • Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company's Quality Policies, industry standards and local GMP/GDP related regulatory requirements
  • Manage Affiliate documentation and training records within Idorsia Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes.
  • Ensure the provision of appropriate quality related training for regulated activities in affiliates and monitor training compliance.
  • Ensure appropriate and timely management of nonconformances related to relevant GxP (GMP/GDP): deviations, change controls, internal and external CAPAs, Quality Events.
  • Monitor quality system performance versus local quality relevant GxP and Idorsia requirements via use of pertinent quality and compliance metrics and goals, in alignment with HQ QA guidance and principles. As needed, collaborate with HQ QA for reflecting the affiliate indicators specifics in the HQ quality performance management review.
  • In charge of affiliate Quality Management Review in collaboration with Local Responsible Person for medicinal product distribution/wholesale, if applicable. Escalate as needed to HQ QA the highlights of the affiliate's review.
  • Notify and engage HQ QA and other affected stakeholders with any substantial concerns regarding product quality, safety and/or compliance, as per the escalation procedures.
  • Lead / support in collaboration with HQ QA external audit and inspection and report and track these and any other relevant field action activity into the relevant quality systems. Ensure that the affiliate quality system is in constant state of readiness for planned and ad hoc audits or inspections. This activity should be performed as appropriate in collaboration with EU QPPV/National QPPV/Affiliate Safety Manager, the Local Responsible Person and any other relevant stakeholders.
  • Ensure local PV related vendors/external partners in the affiliates are qualified (Approved Supplier List) and are appropriately monitored/audited against relevant company and local standards.
  • Based on local requirement, conduct as appropriate GxP related selfinspections that are applicable to the affiliate activities, respectively perform internal audits/selfinspections of other affiliates.
  • In interaction with the Local responsible person and HQ QA, process Product Quality Complaints through relevant electronic systems, escalate critical product issues and support execution of (mock) recalls and other (mock) field actions in a timely manner.
  • Evaluate changes and proposed changes to country specific laws and regulations related to quality (GMP/GDP). Keeping Affiliate Management and HQ QA informed about significant changes and maintaining an updated record of applicable country specific laws, regulations, requirements and regulatory procedures related to quality (GMP/GDP). Support the ASM to conduct impact assessment for new or updated PV regulations.
  • Take care of lifecycle of Commercial Quality related documentation to ensure proper documents storage and archiving, in alignment and in collaboration with HQ QA following Idorsia archiving principles.
  • Participate to Industry Association/Working Groups where present to anticipate, analyze current/emerging regulations/trends that impact Quality System, as appropriate.
  • Use best (industry) practice to implement and support local continuous process excellence and improvement activities, and collaborate

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