Job Detail

Company Description

The Head of Standards and Governance (S&G) for Biosimilar Business Unit (BBU) is responsible for driving governance and the

implementation of the Corporate Compliance Program while working in close partnership with the designated Corporate Compliance

Officer (CO) and local business departments globally. S&G provides operational support to the business unit on matters related to

meeting the license agreements with Samsung Bioepis (SB), Biogen Corporate Compliance SOPs/Policy implementation, coordination

of the audits, audit remediation and risk management. S&G supports the cross functional teams when they engage external stakeholders

through various activities ( Speaker programs , Advisory boards, sponsorship etc). S&G supports the quarterly monitoring exercise 

undertaken by Compliance and the resulting corrective actions. S&G is an expert trainer on  compliance topics and delivers / facilitates

the training as per the agreed upon training plan. S&G in consultation with the privacy office will also provide operational support to

the team on topics related to the data privacy.

S&G will support the newer geographical / therapeutic expansion plan of the BBU by coordinating with the counterparts in the new

geographies to ensure that the relevant procedures are in place as required and the biosimilar colleagues are well trained on these

requirements.

Job Description

1.Corporate Compliance support and Governance oversight 

• Perform monthly monitoring of BU Compliance training 


• Support Corporate Compliance quarterly monitoring activities  


• Participate in implementation of business processes (supporting CO and other respective functions), Global SOP implementation, Record Management, and support Work Instructions & Job Aids design, support new compliance related systems implementation, etc)  


• Collaborate cross-functionally and cross geographically to ensure support wherever needed and provide day-to-day advice as to adherence to, and requirements of, Samsung agreements, Global processes and Policy requirements (eg. FMV, etc.) 


• Support Monitoring / Audit remediation  


• Support  “Speak Up”  and “Tone from the Top” awareness activities.  

2.Meetings and Sponsorships and other aspects of Grants & Giving 

• Ensure compliance with the Global Minimum Standards along with Grants and Giving Global guidance and provide support in the execution of this guidance ensuring an agile approach 


• Sponsorship SME in terms or process, tools, support, system enhancements 


• Supports in navigating the meeting / sponsorship process to ensure the correct processes are being followed 

3.Training Coordinator for the BBU-HQ 

• BBU contact person for the Learning Management Systems (BU), and liaison between BBU and Global/Regions. 


• Maintain BBU Compliance training program requirements and records (ie COBC) 


• Lead and coordinate Governance and training processes within non-GxP area (owning administration of (non-GxP) controlled documents, maintaining training matrixes for non-GxP requirements, inform monthly monitoring of BU training compliance

4.Standard and Governance Committee  

• Lead, plan and document the Standard and Governance Committee (SGC) and run it on a monthly basis

5.Support Geographical Expansion of the BBU 

• Collaborate with counterparts and business colleagues in the new geographies to understand unique requirements if any and ensure that BBU specific procedures are incorporated in the affiliate training plans.

6.Data Privacy 

• Support Data Privacy office to ensure compliance of ‘The GDPR’ and Global Privacy program. 
   

Qualifications

•  Bachelor’s degree in law, nature science or any other relevant


• A minimum of >10 years of experience in a similar role, ideally in pharmaceutical or biotechnology industries 


• Knowledge of Healthcare Compliance Program requirements or experience in other defined governance roles (Audit, GxP, Regulatory Affairs, Business Compliance etc.)