Biogen

Full-time Region: EU+/Canada Department: Manufacturing Job Description About the role Location Baar, Switzerland as per local HR hybrid policy Travel: Ability to travel domestically and internationally as needed. You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and be responsible for driving strategic initiatives for business growth and operational excellence. Responsible for up to 5 CDMO sites and up to $100m in spend, they will ensure supplier performance meets quality, cost, and delivery specifications, and be responsible for establishing and adhering to external manufacturing budget for designated sites. This role includes driving continuous improvements in efficiency, quality, and cost-effectiveness across manufacturing processes. You will establish and maintain strong partnerships with external partners to foster effective collaboration and long-term success. Leading cross-functional teams, they will address complex manufacturing issues and ensure compliance with regulatory requirements. You will be responsible for CDMO site selection, contract negotiation, and aligning manufacturing strategies with internal stakeholders. Your leadership will also involve liaising with governmental agencies as needed to uphold operational standards. Collaboration with the cross-functional stakeholders will be key in facilitating technology transfers and validations. You will lead a small team of direct reports. What you'll do Advocate for and represent a team of External Site Leads in global leadership teams and present high-level project risks, milestones, and stage gates to senior leadership. Collaborate globally with directors and managers of other line functions to ensure delivery of process transfers to the timelines required by the Asset Development Program Management Teams. Identify, define, and lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes for external manufacturing technical operations. Directs the implementation of the agreed-upon solutions and is accountable for the effectiveness of new process(es). Cultivate continuous improvement environment within tech transfer teams at both internal and external sites. Understand and respond to global supplier cluster business priorities and translate these into tactical objectives. Ensures technical alignment of all functions within external manufacturing and PO&T for responsible Supplier cluster. Manage budget, staffing, and performance management duties for the team. Provide technical direction, leadership, and development to people leaders and individual contributors. Ensure compliance of external technical operations within with both Biogen procedures and cGXP regulations and guidelines. Ensure that all external manufacturing protocols and reports are compliant with both agency expectations for their respective locations and modalities. Revenue Impact and Spend Oversight Who you are Experience with supplier relationship management. Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams. Strong negotiation skills. Strong technical proficiency within fill and finish development and manufacturing is a must. Experience across modalities required. Qualifications Education: Masters or Ph.D. in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. Minimum 12 years of experience in biotech/pharmaceutical cGMP manufacturing industry. Experience with supplier relationship management. Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams. Strong negotiation skills demonstrated in prior roles Strong technical proficiency within fill and finish development and manufacturing is a must Experience across modalities required. 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. Read on to learn more about our DE&I efforts.

Full-time Region: EU+/Canada Department: Quality Job Description About the role Location: Baar, Switzerland as per our hybrid HR policy You provide/ensure quality assurance oversight of distributed products in markets where Biogen products are commercialized. Define Affiliate Quality Management systems required to meet cGDP and other applicable regulations and ensure compliance of local QMS with Biogen-s global quality system requirements, relevant regulatory requirements, and applicable licenses. In this leadership role you oversee and define Quality requirements to Partner Markets and assure QA market specific requirements from Biogen are communicated to required stakeholders. Ensure Quality oversight for product shipping and storage conditions, including compliance against the submitted dossier with local health authorities. You as well ensure all Quality distribution requirements are implemented to support market expansion launch activities. Collaborate with all necessary stakeholder functions and ensure Quality is represented in cross functional decisions. You lead a global team and influence Quality collaboration and decision making with non-direct reporting QA colleagues. You will report to the Head of External and International Quality. What you'll do 1.Provide quality assurance strategy, decision making and support in Affiliate and Partner Markets: . Ensure Affiliate License compliance for distribution activities through identification and monitoring of regulations, reviewing licensing requirements and support license changes and applications when needed. . Establish GxP system and procedures to support new affiliate operations and licenses. Define systems as required to support GxP activities at the affiliates (e.g. documentation management, training, audit, deviation, CAPAs, change control, Management Review, risk management, Quality Agreements, customer qualification, product release, falsified medicines). . Ensure appropriateness and alignment of Global Quality Management Systems with affiliate requirements. . Drive inspection readiness and coordination of health authority inspections at Affiliate and Partner Markets. . Establish and monitor appropriate KPI tracking and reporting. . Collaborate with required functions to support audits and facilitate remediation of audit findings. . Ensure Quality oversight of in country method transfer activities; oversee in-country testing and coordinate supply of standards to enable product testing and release. . Foster Quality culture at all Affiliates. 2. Oversee Biogen International Distribution for Commercial and Expanded Access Programs . Oversee logistics related QMS and worldwide distribution including central warehouse management and shipping.. . Coordinate qualification of logistics partners and customers with Affiliates/Distribution Partners and External Audit Teams. . Develop and maintain quality agreements with logistics partners, wholesalers, warehousing and distribution partners . Support supply chain efforts to maintain OTIF; distribution model changes and serialization efforts. . Provide quality assurance oversight for Managed Access Programs 3. Manage Product Related issues in market . Support Recall Process and activities as defined by the recall committee . Monitor market activities and escalate issues appropriately . Minimize and manage out of stock situations. . Coordinate and manage communications with regulatory authorities related to product shortage 4. Manage direct reports and managers of managers to increase their performance and effectiveness: . Provide operational guidance and support to reports . Support employee development Qualifications BS degree in related field (PharmD, PhD or advanced degree strongly preferred) Minimum of 15 years of experience in leadership roles preferable in pharmaceutical industry. Previous experience in GDP and distribution of pharmaceutical products Quality and Compliance experience consistent with world-wide regulatory requirements, including working knowledge in ISO requirements/Certification Process Expert knowledge of US and International cGxPs, ISO, ICH and Device regulation Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices Ability to hire and retain top talent Track record of developing and leading leaders Ability to influence the organization Flexible when priorities change Strong leadership abilities required to effectively implement change management strategies Demonstrated ability to successfully manage conflicts and solve problems Excellent oral and written communication skills. Through knowledge of FDA, EU and ROW regulations as they related to GDP and GMP requirements. Proficiency in English, other languages are an asset. 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. Read on to learn more about our DE&I efforts.

Full-time Region: EU+/Canada Department: Human Resources Job Description About the role In this role you support the HRBP Team on activities within Biogen Baar and add value to the business in pursuit of their objectives and the overall business goals. Here you contribute to create, adapt and implement Human Resources (HR) plans in Baar that drive optimal business performance and ensure these are in line with HR polices and standards. You will report to the Baar International Headquarters (IHQ) HR Site Leader Full time, employment contract of limited duration Location:Baar, Switzerland as per our hybrid local HR policy What you'll do HR Business Partner: Meeting point for the resolution of doubts and support for the different business units and office staff in the area of human resources processes and procedures. You provide support to the management on all HR related topics. HR Projects: Manage different projects in the HR area; HR and cultural transformation, company culture, employee engagement and well-being. HR Administration: Monitor and collaborate in the support and continuous improvements of HR processes with the HR shared operations team and external partners (benefits and payroll). Manage local benefits. HR Communication: drive and manage internal HR communication e.g monthly newsletters, info sessions, new starter onboarding. Talent & Performance: Support talent management and compensation processes. Monitoring of onboarding, performance evaluation, compensation process (merit increases, bonus payout and LTI), annual calibration, goal getting and organizational talent review. What we offer You contribute to maintain a workplace where people are fully engaged pioneers and can work in a smart and efficient way. Have ability to work across functions and within teams, with strong interpersonal and communication skills. This role is ideal for a self-starter and who likes to manage multiple projects concurrently as well as work in international fast pace environment. Qualifications Commercial degree and further certification on HR Professional expertise in the HR field (at least 4 years) Preferably experience in multinational companies, with some working experience in the pharmaceutical or FMCG industry Demonstrated experience in project management and consultancy environment. Demonstrated experience building customer relationships and proficient consulting skills. Well-rounded expertise in various Office 365 programs such as Work, Excel and PowerPoint Passionate for Human Resources topics Ability to manage multiple business priorities effectively Attention for details and strong sense of accountability Previous knowledge in Workday is a plus Fluent in English; German language skills are a strong advantage 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. Read on to learn more about our DE&I efforts.