Sr. Associate III, External Auditor / GMP Auditor
About This Role
As a key contributor within the Corporate Quality organization, the Sr. Associate III, External Audit will be primarily responsible for performing external audits of Biogen vendors and suppliers.
What You’ll Do
- Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external suppliers/ vendors/ service providers such as contract manufacturing organizations, suppliers of raw materials, laboratory operations, logistics providers, and GMP service providers.
- Assembly and coordination of the audit team, preparation of the audit plan, leading the audit, writing audit reports and follow-up letters.
- Ensure that the appropriate remediation/ CAPAs are in place for any GMP deficiencies found during audits.
- Participation in vendor change notification assessments
- Perform material/ vendor risk assessments
- Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance at external vendors
- Responsibilities also include successfully completing and maintaining current job training requirements.
Who You Are
You are driven by performing risk assessments and gap analyses for compliance and business risk. You are passionate about working across cultures and departments, and conducting audits across different organizations. Switzerland/Europe travel expected for this position is ~50% with some international travel expected.
Required Skills
- BS or advanced degree in a scientific field is preferable.
- At least 5 years of experience working with drug substance/drug product manufacturing, Quality Control and/or Quality Assurance is required, combined with a minimum of 2 years of cGMP auditing experience in the pharmaceutical and/or biotechnical arenas.
- Certified Quality Auditor (CQA) designation is beneficial.
- General knowledge of regulatory requirements for the pharmaceutical/ biotechnology industry is required.
- You can work independently, in a team environment and across cultures.
- You have excellent communication skills, both verbal and written in English, additional language skills is a plus.
- You have excellent typing skills and are proficient in the use of Microsoft Word, Excel and Powerpoint applications.
As a key contributor within the Corporate Quality organization, you will be primarily responsible for performing external audits of Biogen vendors and suppliers. You will have the ability to effectively communicate compliance issues and expectations with Biogen internal customers, management, and external vendors/ suppliers.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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 our DE&I efforts
