Sr. Auditor, External Supplier Quality

vor 5 Monaten

Berlin, Deutschland AbbVie Vollzeit

**Company Description**
**Job Description** Purpose**:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide

**Responsibilities**:

- Independently plan and conduct internal system audits and external GxP supplier audits
- Maintain approved supplier list, global audit schedule and participate in supplier management processes
- Gathers internal and external audit metrics and presents to QA management for trend analysis
- Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
- Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel
- Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Leads goals with cross-functional or broader scope. Resolves project team issues with mínimal oversight
- This is an experienced level compliance position that reports to the Associate Director GxP Compliance. This individual is expected to identify and resolve problems, through effective interpersonal skills. The incumbent will work effectively independently,

**Qualifications** Qualifications**:

- Bachelor’s degree preferably in life sciences or engineering
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies
- 5+ years’ experience in function or related fields such as: thorough understanding of international GxP regulatory standards (e.g. GMP, GLP, GCP, GDP, GCLP, etc.), Quality Assurance / Regulatory Affairs, Pharmaceutical / Device / Healthcare Industry, Quality Assurance auditing experience (preferred), Laboratory experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA)

**Additional Information**
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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