Sr Associate I, Internal Auditor
vor 2 Wochen
**Job Description**:
About this role:
As a key contributor within the Corporate Quality organization, Internal Auditor will be primarily responsible for performing internal audits of Biogen GMP facilties and quality systems. The individual will have the ability to effectively communicate compliance issues and expectations with Biogen internal functions and management, and have the ability to perform risk assessments and gap analyses for compliance and business risks. Secondarily, the Sr. Associate I, Internal Auditor may be responsible for carrying out audits of external vendors to Biogen on occasion.
**What you'll do**:
- Coordinate, conduct, and provide follow-up for audits and/or assessments of internal Biogen GMP functional areas, processes, quality systems and their implementation.
- 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 response and CAPA tracking from Regulatory Agency inspection of Biogen sites.
- Possess and maintain knowledge of current global GMP regulatory requirements and industry trends to ensure compliance
- 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.
**Qualifications**:
**Required Skills**:
- BS in a scientific field is preferable.
- Minimum 4 years related compliance or auditing experience in the pharmaceutical and/or biotechnical arenas.
- Previous experience in drug substance/drug product manufacturing, Quality Control and/or Quality Assurance is required.
- cGMP auditing experience is required.
- General knowledge of regulatory requirements for the pharmaceutical/ biotechnology industry is required.
- The individual must have excellent communication skills, both verbal and written.
- Can work independently, in a team environment and across cultures.
- Domestic and international travel expected for this position is ~10 / 15%
**Preferred Skills**:
- Certified Quality Auditor (CQA) designation is beneficial.
Additional Information
**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.
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