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). As the Deputy RP/FvP, you will be 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. You will ensure 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:

• You will have the authority to issue directives and to take decisions with regards to your responsibilities, independently of Biogen Management and the Swiss Affiliate Leadership Team.
• You will ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO, Cantonal Laws and Regulations etc.) and internal regulations. You will focus on the management of authorized activities, the accuracy and quality of records.
• You will 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 your capacity as Deputy RP/FvP:

• You will decide and perform independently on final release of batches to the Swiss market, according to local legislation.
• You will manage, report and document product returns including decision on re-integration to saleable stock.
• You will decide independently from Biogen Management and Swiss Affiliate Leadership Team on disposition of rejected, recalled, falsified and expired products.
• You will manage Product Quality Review (PQR/AQP) Assessments as per applicable SOPs and local law.
• You will ensure Inspection readiness of the applicable Operational License activities, e.g. import and wholesales activities.
• You will ensure timely renewal and update, if applicable, of Operational Licenses per Swissmedic License Application Process (min 6 month before expiry of license).
• You will be knowledgeable on GMP/GDP and changing Regulatory requirements and ensure appropriateness of licenses and distribution models to distribute medicinal products.
• You will ensure that suppliers and customers are approved in coordination with responsible departments.
• You will approve any sub-contracted activities, which may have an impact on GMP/GDP regulations, and be responsible for qualification and monitoring of such activities
• You will develop and maintain local Quality Agreements.
• You will ensure that any additional requirements imposed on certain products by local Regulatory Bodies are adhered to.
• You will develop and maintain local procedures in alignment with the local regulations and Global QMS
• You will manage locally initiated and continuous training program including GxP training
• You will 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)
• You will host local Health Authority inspections and Internal Affiliate Audits including readiness and follow up before, during and after the inspection/audits. You will coordinate related follow ups and CAPA development and implementation
• You will lead, develop and coordinate local Self-Inspection program as per schedule, including risk assessment, and leads related follow ups and CAPA development and implementation
• You will 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. You will request additional CAPAs if deemed necessary to comply to GMP/GDP Regulations and local registration requirements
• You will ensure Technical Product Complaints (TPCs) are handled as per local and Global procedures and support TPC-related investigations and follow-ups, as necessary.
• You will ensure that customer complaints are addressed appropriately and dealt effectively.
• You will execute recalls in collaboration with local and global Recall Committees upon approval by Swissmedic. You will act as local coordinator of a recall to be performed on the Swiss territory, including Lichtenstein. You will compile the local recall report upon closure of the recall by Swissmedic. You will follow-up on additional request by Swissmedic after closure of the recall (e.g. CAPA implementation) You will ensure that suspected falsified products are immediately notified for investigation and coordinate local management of the issue.
• You will manage temperature excursion assessments and finally decide on usability of affected products.
• You will cooperate with all necessary departments to ensure that communication to Health Authorities is appropriate, coordinated and approved.

As Manager, Quality Assurance:

• You will 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)
• You will 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)
• You will foster Quality understanding at Affiliate management by providing QA operational support, guidance and supervision in Affiliate markets
• You will manage Quality System for Affiliates to ensure all Biogen and applicable GxP regulations are met
• You will ensure Affiliate QMS complies to Biogen Global QMS
• You will ensure Biogen Global QMS is aligned and appropriate with Affiliates' requirements
• You will manage Quality Management Review process for Affiliates
• You will oversee appropriate Affiliate GxP vendor management program
• You will support Affiliate audits and Health Authority Inspections with readiness/coordination/follow up
• You will support Audits to Distribution partners
• You will support drafting and review of Affiliate's GxP related documents
• You will oversee and approve local quality records (deviations, Planned Exceptions, CAPAs, Audit Module, and Change Controls)
• You will support temperature excursion assessments to external customers
• You will approve exceptional in-country repackaging activities
• You will develop, establish and maintains Quality Agreements with external partners
• You will assess regulatory environment to ascertain GxP requirements which may impact supply chain
• You will ensure continuous supply of product and support product launches
• You will support Distribution Model changes and product serialization
• You will support coordination of the Recall process and recall activities as defined by the Recall Committee. You will monitor market activities and distributed product issues, and escalate immediately issues to appropriate responsible such as DMRB or Product Security
• You will minimize out of stock situations in coordination with other functions

Who You Are:

You are a highly skilled and experienced professional with a strong background in Quality Assurance and Regulatory Affairs. You have a proven track record in managing quality systems, ensuring compliance with regulatory requirements, and leading cross-functional teams. You are fluent in German and English, and have a high level of integrity and sense of business partnership. You are skilled at understanding processes and keeping the overview even in complex settings and when dealing with multiple parallel or integrated processes. You have policy and process development and implementation experience, and are action-oriented, working efficiently and methodically, constantly moving forward to achieve set goals. You are intellectually sharp and fast-thinking, with managerial courage. You work in an organized way, using resources effectively. You have excellent conceptual, strategic and analytical skills, and are interpersonally savvy, working comfortably in cross-functional teams and flexible when priorities shift. You have good intercultural awareness, and the ability to prioritize and handle multiple tasks. You have sound training experience, including developing material and providing trainings. You have the capacity to manage conflicts and solve problems.

Qualifications

• You have a higher education in pharmaceutical or natural sciences, with a minimum of Master Level, preferably PhD or Pharmacist.
• You have Swissmedic Technical Interpretation I-SMI.TI.17.
• You have at least 5 years' experience in pharmaceutical or related industry in the field of QA/RA.
• You have a track record in the field of QA including registrations, audits & inspections.
• You are fluent in English and German (speaking & writing).
• You are willing to continuously learn.
• You have good knowledge of Biogen procedural documents, International Guidelines such as ICH/GCP etc.
• You have good understanding of regulations in GMP and GDP, good knowledge of certification processes
• You have good project management skills.
• You have good knowledge of PC (Word, Excel, PowerPoint) and special applications

Additional Information

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.