Sr. Associate Ii, External Audit

Vor 4 Tagen

Baar, Schweiz Biogen Vollzeit

**Job Description**:
**About This Role**

As a key contributor within the Corporate Quality organization, the Sr. Associate II, Corporate Quality 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.

**Qualifications**:
**Who You Are**

You are passionate about working across cultures and departments, and conducting audits across different organizations and regions of the Globe.

**Required Skills**:

- BS or advanced degree in a scientific field.
- Minimum 10 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. Certified Quality Auditor (CQA) designation is beneficial.
- General knowledge of regulatory requirements for the pharmaceutical/ biotechnology industry is required.
- Can work independently, in a team environment and across cultures.
- The individual must have excellent communication skills, both verbal and written in English, additional language skills is a plus (Mandarin, Korean or Japanese).
- Domestic and international travel expected for this position is ~50%.

Additional Information

The Sr. Associate II, Corporate Quality will have the ability to effectively communicate compliance issues and expectations with Biogen internal customers, management, and external vendors/ suppliers. The individual will have the ability to perform risk assessments and gap analyses for compliance and business risks.

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