Quality Assurance Manager & Deputy of the Responsible Person

About the role:

Location: Baar Switzerland

• In this role you act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP), according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR 812.212.1, Arts., 12, 13, 17, 18 and the Swissmedic Technical Interpretation I-SMI.TI.17, within Biogen Switzerland AG (Swiss Affiliate). In their role, the RP/FvP is the main contact for Quality Assurance (QA) topics to distributors and external bodies (e.g. Swissmedic) and responsible for the quality of distributed medicinal products (GMP/GDP).
• You oversee quality assurance and support GxP activities at Biogen Affiliates and Distribution partners to ensure product quality all the way to patient. Ensures control of the distribution chain to maintain quality and integrity of medicinal products, new product launches and product related issues in cooperation with the different functional areas.

What you'll do:

As the Deputy RP/FvP for Biogen Switzerland AG:

• Has the authority to issue directives and to take decisions with regards to their responsibilities, independently of Biogen Management and the Swiss Affiliate Leadership Team.
• Ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO, Cantonal Laws and Regulations etc.) and internal regulations. Focusing on the management of authorized activities, the accuracy and quality of records.
• Ensure that all medicinal products are handled appropriately, in particular as it concerns the monitoring of product specification (including Certificates of Compliance), testing instructions, storage conditions, expiry dates and quality standards.

In their capacity as Deputy RP/FvP:

• Decides and perform independently on final release of batches to the Swiss market, according to local legislation.
• Manage, report and document product returns including decision on re-integration to saleable stock.
• Decide independently from Biogen Management and Swiss Affiliate Leadership Team on disposition of rejected, recalled, falsified and expired products.
• Manage Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local law.
• Ensure Inspection readiness of the applicable Operational License activities, e.g. import and wholesales activities.
• Ensure timely renewal and update, if applicable, of Operational Licenses per Swissmedic License Application Process (min 6 month before expiry of license).
• Knowledgeable on GMP/GDP and changing Regulatory requirements and ensure appropriateness of licenses and distribution models to distribute medicinal products.
• Ensure that suppliers and customers are approved in coordination with responsible departments.
• Approve any sub-contracted activities, which may have an impact on GMP/GDP regulations, and is responsible for qualification and monitoring of such activities
• Develop and maintain local Quality Agreements.
• Ensure that any additional requirements imposed on certain products by local Regulatory Bodies are adhered to.
• Develop and maintain local procedures in alignment with the local regulations and Global QMS
• Manage locally initiated and continuous training program including GxP training
• Oversee and approve local quality records (deviations, CAPAs and Change Controls) and supports as needed other quality related tasks (Audit Module, Technical Product Complaints, Planned Exceptions)
• Host local Health Authority inspections and Internal Affiliate Audits including readiness and follow up before, during and after the inspection/audits. Coordinates related follow ups and CAPA development and implementation
• Lead, develop and coordinate local Self-Inspection program as per schedule, including risk assessment, and leads related follow ups and CAPA development and implementation
• Review and evaluate internal audit reports, including CAPAs, of Manufacturer, CMOs, CROs and Service Providers involved in the manufacturing, distribution and storage of medicinal products intended for the Swiss market. Request additional CAPAs if deemed necessary to comply to GMP/GDP Regulations and local registration requirements
• Ensure Technical Product Complaints (TPCs) are handled as per local and Global procedures and
  support TPC-related investigations and follow-ups, as necessary.
• Ensure that customer complaints are addressed appropriately and dealt effectively.
• Execute recalls in collaboration with local and global Recall Committees upon approval by Swissmedic.
  Act as local coordinator of a recall to be performed on the Swiss territory, including Lichtenstein. Compile the local recall report upon closure of the recall by Swissmedic. Follow-up on additional request by Swissmedic after closure of the recall (e.g. CAPA implementation)
  Ensure that suspected falsified products are immediately notified for investigation and coordinate local management of the issue.
• Manage temperature excursion assessments and finally decide on usability of affected products.
• Cooperate with all necessary departments to ensure that communication to Health Authorities is appropriate, coordinated and approved.

As Manager, Quality Assurance:

• Ensure that each Affiliate site maintains compliance to the required regulations in order to maintain appropriate licenses for distribution (e.g. but not limited to: GMP, WDA, MIA, ISO)
• Coordinate activities to establish Affiliate applicable licenses and liaise with all functional areas to meet license requirements (e.g. but not limited to: Compliance, R&D, Commercial, Legal)
• Foster Quality understanding at Affiliate management by providing QA operational support, guidance and supervision in Affiliate markets
• Manage Quality System for Affiliates to ensure all Biogen and applicable GxP regulations are met
• Ensure Affiliate QMS complies to Biogen Global QMS
• Ensure Biogen Global QMS is aligned and appropriate with Affiliates’ requirements
• Manage Quality Management Review process for Affiliates
• Oversee appropriate Affiliate GxP vendor management program
• Support Affiliate audits and Health Authority Inspections with readiness/coordination/follow up
• Support Audits to Distribution partners
• Support drafting and review of Affiliate’s GxP related documents
• Oversee and approve local quality records (deviations, Planned Exceptions, CAPAs, Audit Module, and Change Controls)
• Support temperature excursion assessments to external customers
• Approve exceptional in-country repackaging activities
• Develop, establish and maintains Quality Agreements with external partners
• Assess regulatory environment to ascertain GxP requirements which may impact supply chain
• Ensure continuous supply of product and support product launches
• Support Distribution Model changes and product serialization
• Support coordination of the Recall process and recall activities as defined by the Recall Committee. Monitor market activities and distributed product issues, and escalate immediately issues to appropriate responsible such as DMRB or Product Security
• Minimize out of stock situations in coordination with other functions

Who you are:

Fluent in German and English languague skills. High level of integrity and sense of business partnership. Skilled at understanding processes and keep the overview even in complex settings and when dealing with multiple parallel or integrated processes. Policy and process development and implementation experience. Action oriented, works efficiently and methodically, constantly moving forward to achieve set goals. Intellectually sharp and fast thinker.Managerial courage. Work in an organized way, using resources effectively. Excellent conceptual, strategic and analytical skills.Interpersonally savvy, works comfortably in cross-functional teams and flexible when priorities shift.Good intercultural awareness. Ability to prioritize and handle multiple tasks. Sound training experience including developing material and providing trainings. Capacity to manage conflicts and solve problems.

Requirements

• Higher education in pharmaceutical or natural sciences. Minimum of Master Level, preferably PhD or Pharmacist.
• Swissmedic Technical Interpretation I-SMI.TI.17
• At least 5 years’ experience in pharmaceutical or related industry in the field of QA/RA.
• Track record in the field of QA including registrations, audits & inspections.
• Fluent in English and German (speaking & writing).
• Willingness to continuously learn.
• Good knowledge of Biogen procedural documents, International Guidelines such as ICH/GCP etc.
• Good understanding of regulations in GMP and GDP, good knowledge of certification processes
• Good project management skills.
• Good knowledge of PC (Word, Excel, PowerPoint) and special applications