Sn. Associate II - Delegated Responsible Person

1. Accountable on DS/API to Medicinal Products release and RP delegation for Pharmaceutical

• Ensure appropriate training and organization to perform release on time
• Review and verification of batch release documentation according to local procedures and product specific checklist
• Contribute to technology transfer, launches or improvements projects through establishment of needed release process update
• Collect & Perform Key Process Indicators analyses including feedback from other departments (e.g. Planning). Identify appropriate actions and ensure successful implementation
• Manage Stakeholder as RP delegate for the release activities through SME assessment and decision making
• Perform ALTO investigations in Oracle_PLM to support compliance through change control and release to Market

2. Quality System

• Support local Quality System (change control, deviations, CAPAs, …) as required
• Able to identify and drive improvements/updates of the GMP documentation related to Release activities
• Able to identify any compliance gap in Biogen processes and identify appropriate stakeholder to fix the issue
• Ensure adherence to serialization and data integrity requirements

3. Communication & Build Strategic Work relationship

• Identify and communicate timely to the management any supply risk or risk of batch rejection
• Able to clearly communicate expectations to internal/external customers as well as management
• Able to report status of ongoing activities to the manager/stakeholder and highlight any time/resources constraints and propose action/time reallocation to the manager
• Develop and sustain an internal and external networking

4. Decision Making

• Decisions with patient, global or regulatory impact must be taken in collaboration with upper management
• Prepares information, contributing to reject/recall decisions
• Ability to back-up peers for area of expertise

5. Developing Others

• Leads matrix teams within a product program cross functionally or at global level. May also drive project initiatives.
• Coach indirect report(s), coach other departments on quality regulations and tools, delegate and empower appropriately and build core skills and abilities

6. Innovation/Pioneer

• Identify possibility for improvement/standardization in the purpose of continuous improvement of the system used
• Generate and coordinate continuous improvement projects as well as ensure team commitment to innovation
• Drive new processes set up implementation and train the team

• Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
• A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries.
• Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling). Sound knowledge of cGMP requirements, EU/FDA regulations and compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.

Responsible for disposition pack preparation and act as Responsible Person (RP) delegate for Biologics Drug Substances (DS), Parenteral Drug Products (DP), Parenteral Finished Goods (FG) technical release or Active Pharmaceutical Ingredients (API), Pharmaceutical Drug Products, Pharmaceuticals Finished Goods (FG) technical release.

The RP (Fachtechnisch verantwortliche Person) release delegate is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in the country of destination, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP) for Switzerland for both Biogen International GmbH and Biogen Swiss Manufacturing GmbH.