Job Description
Job summary:
The EMQ team provides technical quality support and supplier quality management for commercial and clinical active substances, drug products and finished goods. The Senior Director is also responsible for the technical release of all products manufactured by the concerned contract manufacturing organisations.
This leader is responsible for communicating quality issues to senior management, managing their resolution, participating in cross functional teams such as Planning, Logistics, External Manufacturing, Manufacturing Sciences, Quality Control, Regulatory Affairs, Patient Services and Safety and Risk Management.
They are accountable to ensure compliance with global regulatory standards at Biogen and third-party facilities and to provides Quality expertise to internal and external partners related to Technology Transfer, Validation and Manufacturing, Investigations/CAPA management, Change and Risk Management.
The holder of this position acts as Responsible Technique / fachtechnisch verantwortliche Person (i.e. Qualified Person) for Switzerland for both Biogen International GmbH and Biogen Swiss Manufacturing GmbH, in the meaning of articles 5, 10 and 14 of the Swiss Ordinance on authorisations relative to medicinal products (812.212.1). As such Qualified Person, the successful candidate is authorized to give directives (also towards management) in her / his area of responsibility.
Principal Accountabilities:
1. Responsible for Quality oversight of Biogen contracted manufacturing operations.
• Develops and maintains strong and effective relationships with internal partners (Manufacturing, Regulatory Affairs, Human Resources, Legal and Finance) to ensure Global Quality goals and objectives are met. Leads, participates in and provides direction to cross-functional teams related to product investigations, regulatory audits/inquiries, implementation of new/revised GxP guidelines, and PO&T strategic improvement initiatives
• Negotiates Quality Agreements with contract manufacturing organizations (CMO) and corporate partners.
• Participates in BIIB Health Authority audits and support Health Authority audits at contract sites.
• Develops and maintains effective relationships with external partners (Collaboration Partners, CMO's and 3PL's) to ensure adherence to Biogen standards, cGMP's and regulatory agency guidelines
• Ensures CMO performance is tracked and reported during Biogen management reviews. If appropriate, and in collaboration with CMOs and concerned internal departments such as external manufacturing or manufacturing sciences, develops and ensures execution and effectiveness verification of CMO improvement action plans.
• Leads Global Supply Chain and CMO management reviews and ensures appropriate corrective and preventive actions are identified and implemented.
• Responsible for the timeliness and accuracy of periodic CMO assessments.
• Responsible for leading strategic initiatives to re-engineer business processes within Global External Manufacturing Quality.
• Makes decisions regarding product disposition including release to market, regulatory reporting and product withdrawal/recall
2. Quality Systems
• Manages QMS for oversight of GxP activities with a focus on external GMP manufacturing and GDP for commercial and clinical products. Ensures manufacture and distribution of Biogen products is performed in a safe, compliant manner, meeting the requirements defined by Biogen regulatory submissions, cGxP requirements and Biogen Quality Agreements.
• Ensure that the Global External Manufacturing Quality QMS is applied at all sites in accordance with the Global QMS
• Ensure that superuser support is maintained for critical business systems, including Oracle, Trackwise, PLM and BIU
• Support global management reviews and central reliability rooms
3. Leads and develop the Global team.
• Recruit, retain and develop strong QA staff responsible for the management of quality operations to ensure the compliance of commercial and clinical products.
• Direct the Global External Manufacturing Quality staff, including personal performance and development, in support of Corporate and Dept goals. Ensure team members are empowered, motivated and have adequate development plans.
• Manages the utilization of Quality resources to ensure on-time supply of products and adherence to financial targets.
4. Product release
• Responsible for the timely technical release of clinical and commercial products to ensure on-time supply of products and adherence to financial targets. Interfaces with other release functions worldwide with regards to product release.
• Acts as Responsible Person (Responsable Technique / fachtechnik verantwortliche Person) for Biogen International GmbH and Biogen Swiss Manufacturing GmbH, in the meaning of ordinance 812.212.1.
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Qualifications
• Minimum of 12 years of experience in the pharmaceutical industry, both on biological and solid forms products development and/or production.
• Minimum of 7 years of experience in Quality associated with biopharmaceutical / pharmaceutical production.
• Minimum of 10 years of experience managing people managers
• Experience in people management and project management as well as experience in managing a Global team across multiple sites
• Strong communication skills (several languages like German and French a plus)
Education
• Ideally a Pharmacist, PhD, MS in Biological Sciences, or BS in Chemical Engineering or any other relevant background. Must comply with requirements in articles 5, 10 and 14 of the Swiss Ordinance on establishment licenses (812.212.1).