Deputy Quality Assurance Manager

About the Role:

Location: Baar, Switzerland

• In this role, you will 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 will 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.

Responsibilities:

• 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.

Key Responsibilities:

• Decides and performs 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.

About You:

Fluent in German and English language 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.

Qualifications:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.