Job Detail

Job Description

• Contribute to the development and management of the Annual Affiliate Audit Schedule (5%)


• Schedule, prepare, conduct and report Affiliate audit and compliance monitoring activities to ensure compliance with cGMP and GDP. (40%)


• Document and maintain a distribution paradigm for Affiliate sites and contribute to the planning and logistics for a Market Audit paradigm (affiliate, distribution, GXP outsource vendors). (10%)


• Create and maintain a view into each Market that Biogen has commercial product in; including an understanding of the distribution paradigm, mapping of regulations and requirements to each country for areas such as product recall for both Global and local requirements, work with International Affiliate Quality to determine scope and compliance of each Market. (15%)


• Ensure timely responses to audit observations and the follow-up of proposed actions where required (10%)


• Create reports and track follow-up of observations using the Track Wise Audit Management System; provide support to auditees required to provide responses through the same system. (10%)


• Perform peer review of audit reports for colleagues (5%)


•  Identify potential risks, areas of process improvement or trends from the various audits and communicate recommendations to management (5%)


• Assist with the development of metrics (track and trending) reports and presentation of outcomes to Biogen Business Owners (5%)


• Assist and participate in regulatory inspection activities as required

Qualifications

• Minimum of 10 years of Quality Assurance/Compliance experience with at least 5 years of auditing experience is required


• Experience with GDP, GMP is required.  Pharmacovigilance and drug safety experience is also a benefit although not required


• Ability to influence others, create open dialogue and work towards common goals


• Excellent communication skills


• Fluency in English (written and spoken) is a must


• A Minimum BA degree in science or any other relevant background

Additional Information

Conduct and manage audit activities that serve to periodically monitor compliance of the affiliate offices with Biogen policies and procedures and applicable regulatory requirements.  As a member of the Auditing group ensure that audits are planned, conducted, followed up and managed in accordance with procedures as part of a Quality Management System that allows Biogen Affiliates to achieve a high standard of compliance with regulatory guidance.