Athlone, Leinster, Ireland · On-site
About This Role: As the Quality Compliance Lead, you will provide strategic, tactical, and operational leadership to ensure the Quality organization consistently meets site quality, manufacturing, and regulatory objectiv…
Skills: Quality Management System, cGMP Compliance, Inspection Readiness, CAPA, Change Control
Athlone, Leinster, Ireland · On-site
About This Role: As the Associate Director of Quality Control at our Athlone site, you will be a pivotal leader in ensuring the integrity and compliance of our Quality Control operations. This role is crucial for establi…
Skills: Quality Control, GMP Compliance, Personnel Management, Project Management, Analytical Method Transfer
Warsaw, Masovian Voivodeship, Poland · Hybrid
$122k–$163k/yr
. Job Level: Professional Additional Information The base compensation range for this role is: zł122,000.00-zł163,250.00 Benefits Competitive Total Rewards: Base salary is determined by your experience, skills, and inter…
Skills: Clinical Program Sourcing, Contracting Management, Clinical Procurement, Vendor Management, Strategic Sourcing
Cambridge, Massachusetts, United States · Hybrid
$109k–$146k/yr
About This Role As the Manager of Corporate Finance, you will play a pivotal role within our Corporate FP&A team, reporting directly to the Head of Corporate FP&A. You will have regular interactions with the Head of FP&A…
Skills: Financial Modeling, Scenario Planning, Valuation Methodologies, Corporate Finance, Strategic Planning
Munich, Bavaria, Germany · Hybrid
For our office in München (hybrid working model) suchen wir aktuell einen Trainee CE&O Germany. The CE&O Trainee Program is an 18-month structured development track within Customer Engagement & Operations (CE&O), designe…
Skills: Data Analysis, Market Research, KPI Dashboarding, CRM Systems, Omnichannel Strategy
Dubai, Dubai, United Arab Emirates · On-site
About This Role As an Area Business Manager, Rare Diseases, you will play a critical role in driving patient identification, market development, and commercial success across the UAE and selected Gulf markets for Biogen’…
Skills: Territory Management, Account Management, Patient Identification, Market Development, Stakeholder Engagement
Cambridge, Massachusetts, United States · Hybrid
$121k–$162k/yr
About This Role: We are seeking a Manager, IT Data Integration Lead - Omnichannel & Analytics to serve as the primary bridge between US Commercial business stakeholders and cross-functional IT delivery teams. This role i…
Skills: Systems Integration, Requirements Management, Snowflake, Databricks, Veeva CRM
Research Triangle Park, North Carolina, United States · On-site
$93k–$121k/yr
About This Role We are seeking an experienced technical contributor to join our Automation Systems Engineering team at the Biogen RTP Bio site. The Senior Automation Engineer I will support Syncade (MES) system administr…
Skills: Syncade MES, System Administration, GMP Compliance, Electronic Batch Records, GxP
Baar, Zug, Switzerland · Hybrid
About This Role: As the International Commercial Lead for Alzheimer’s Disease, you will drive performance, strategic direction, and commercialization excellence across diverse international markets. This pivotal role inv…
Skills: Commercialization Strategy, Alliance Management, Stakeholder Management, Product Lifecycle Management, Financial Acumen
Baar, Zug, Switzerland · Hybrid
About This Role: As the Associate Director of International Auditing, you will spearhead the planning, execution, and oversight of Quality audits across manufacturing sites, affiliates, contract manufacturers, suppliers,…
Skills: Quality Auditing, GxP Auditing, People Management, Risk-Based Audit Planning, Regulatory Compliance
Riyadh, Riyadh Region, Saudi Arabia · Hybrid
About This Role As an Associate Clinical Country & Site Lead, you will be in an external-facing, country-aligned clinical operations position focused on providing key local operational and scientific knowledge to support…
Skills: Clinical Research, Sponsor Oversight, ICH-GCP, Project Management, CRO Management
Cambridge, Massachusetts, United States · Hybrid
$154k–$212k/yr
About This Role: As the Associate Director of PRC Marketing Operations, you will be instrumental in ensuring a high-quality and efficient content approval process within our marketing operations department. You will over…
Skills: Promotional Material Review, Veeva Vault PromoMats, KPI Reporting, Conflict Management, Negotiation
United States · Remote OK
$184k–$253k/yr
About This Role: The Associate Director Clinical Development, Immunology, based within Biogen’s West Coast Hub (WCH), will contribute to the clinical trial design and execution of one or more Immunology programs, focus o…
Skills: Clinical Trial Design, Medical Monitoring, Neuroimmunology, Autoimmune Disease Expertise, Protocol Development
Baar, Zug, Switzerland · Hybrid
About This Role: As the Lead Value and Access for Switzerland and Austria, you will play a pivotal role in designing and implementing strategies to maximize the value recognition of our drug portfolio among payors. You w…
Skills: Pricing Strategy, Reimbursement Negotiation, Government Affairs, Stakeholder Management, Market Access
Cambridge, Massachusetts, United States · Hybrid
$122k–$163k/yr
About This Role The Biomarkers and Systems Biology group is seeking a highly motivated Senior Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic…
Skills: Ligand-Binding Assays, Cell-Based Assays, PK/PD Biomarker Methods, ADA/NAb Assay Development, CRO Management
Tokyo, Japan · Hybrid
Job Summary: 特定のプロジェクトチームの日本の薬事担当者として、薬事戦略の策定及び実施に積極的に貢献し、必要に応じて関連する規制当局と交渉を行う役割を担う。 日本のライフサイクルマネジメントを含め、新薬の承認申請資料の作成プロセスを管理する。 Job Duties: 規制に関する十分な知識に基づき、開発の全段階（第I相以前から市販まで）において担当するプロジェクトやプログラムの薬事戦略の策定と実施に積極的に貢献する責任を負う…
Skills: Regulatory Strategy, Regulatory Affairs, Lifecycle Management, Regulatory Negotiation, Submission Management
São Paulo, São Paulo, Brazil · Hybrid
Sobre o cargo: O(a) estagiário(a) de Planejamento Financeiro (FP&A) terá uma experiência abrangente em Finanças, apoiando a área de contabilidade e tesouraria. Principais Responsabilidades · Apoiar a análise de variações…
Skills: Financial Planning and Analysis, Budgeting, Forecasting, Variance Analysis, Advanced Excel
United States · On-site
$171k–$236k/yr
Senior National Account Manager, Specialty Channel (Field-Based) About This Role The Senior National Account Manager (AM), Specialty Channel is responsible for managing the relationship and activities within Specialty Ph…
Skills: Specialty Pharmacy Account Management, Contract Negotiation, Business Planning, Analytical Skills, Excel Pivot Tables
Cambridge, Massachusetts, United States · Hybrid
About the Role: This role serves as a key member of the Medical Excellence and Operations team, supporting both Medical Excellence initiatives and Therapeutic Area Strategy & Operations activities that enable Field Medic…
Skills: Project Management, Portfolio Management, Stakeholder Engagement, Budget Management, Financial Forecasting
Milan, Lombardy, Italy · Hybrid
Area geografica di riferimento: Toscana, Liguria, Emilia-Romagna, Umbria & Marche Residenza/Domicilio : Emilia Romagna Retribuzione iniziale: Retribuzione annua lorda 68.000 euroVariabile legato al raggiungimento degli o…
Skills: Scientific Knowledge, Analytical Skills, Organizational Skills, Project Management, Communication Skills
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Lead the site Quality Management System to ensure compliance with cGMP requirements and regulatory objectives. Oversee inspection readiness, regulatory engagement, and provide quality governance across technical functions and QC.
Requires a Bachelor's degree in science and significant experience in GMP sterile manufacturing and health authority inspections. Must have proven people leadership skills and the ability to interpret global regulatory requirements.
About This Role:
As the Quality Compliance Lead, you will provide strategic, tactical, and operational leadership to ensure the Quality organization consistently meets site quality, manufacturing, and regulatory objectives, directly supporting business and site goals. You will lead a high-performing team and assure sustained compliance with cGMP requirements and the Quality Management System. Acting as a senior quality leader and trusted advisor, you will oversee governance and decision-making for both near-term operational execution and long-term site growth. Your role will be integral to batch release, quality systems effectiveness, validation and qualification oversight, and inspection readiness. You will be responsible for driving a continuous Quality and Compliance improvement mindset, reinforcing a strong quality culture across the site while fitting seamlessly into the broader organizational structure.
Lead and improve the effectiveness of the site Quality Management System to deliver compliant, reliable, and inspection-ready outcomes.
Govern site QMS processes, including CAPA, deviations, change control, risk management, documentation, training, and data integrity.
Assess QMS performance through metrics, management review, and inspection feedback.
Drive system-level improvements to address gaps and strengthen process integration.
Lead and manage site inspection readiness and regulatory engagement, maintaining a continuous state of readiness.
Act as the primary site Quality host for regulatory inspections and third-party audits.
Coordinate inspection preparation activities, including mock inspections and risk-based reviews.
Review and approve inspection responses, ensuring commitments are root-cause based and QMS-aligned.
Maintain current knowledge of global and regional regulatory requirements and best practices.
Provide Quality oversight and governance across technical functions & QC ensuring alignment with GMP requirements.
Ensure equipment, utilities, and systems are qualified, controlled, and maintained in a validated state.
Lead and manage cross-functional team participation as a Quality Assurance representative.
Build strong partnerships across various functions to embed Quality perspectives in strategies and initiatives.
Who You Are:
You are a strategic thinker with a strong commitment to quality and compliance. Your leadership skills allow you to inspire and develop teams effectively. You thrive in dynamic environments and excel in managing complex projects with a detail-oriented approach. Your ability to influence and collaborate with cross-functional stakeholders is a key strength, enabling you to drive alignment across diverse teams. You are passionate about fostering a culture of continuous improvement and innovation within the Quality domain.
Bachelor’s degree in science or directly related discipline.
Significant years of experience in the pharmaceutical or biotechnology industry with strong expertise in within GMP Sterile manufacturing environments.
Strong background and experience managing health authority inspections and communications in a pharmaceutical or biotechnology manufacturing site.
Demonstrated experience leading Quality Compliance activities and inspection readiness.
Working knowledge of the lifecycle of GMP equipment, facilities, and computerized systems.
Proven people leadership experience in coaching, developing, and managing professional employees and contractors.
Experience interpreting and applying global regulatory requirements and guidance to site-level quality systems and processes.
Strong written and verbal communication skills.
Advanced degree preferred.
Eligibility for Qualified Person (QP) is a distinct advantage.
Demonstrated ability to influence cross-functional stakeholders and operate effectively within a matrixed environment
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 Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html Follow us on social media – LinkedIn, Instagram, Facebook, X, and YouTube.
Offices: 225 Binney Street, Cambridge, MA 02142, US · Landis & Gyr-Strasse 3, Zug, CH 6300, CH · P.O. Box 14627, 5000 Davis Drive, Research Triangle Park, NC 27709, US
