Principal Quality Assurance GMP External Auditor

Employer
Celgene
Location
Summit, New Jersey, United States
Posted
May 18, 2019
Ref
1900125
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1900125
Location: Summit, New Jersey, United States
Job Category: Quality
Work Location: 556 Morris Avenue 07901
Organization: Quality Operations
Employee Status: Full-time
Job Type: Regular

PURPOSE AND SCOPE OF POSITION:

The position is responsible for GMP/GDP audits of external Contract Service providers and GMP Material Suppliers, assessing compliance with regulatory and Celgene requirements, to identify quality risks, assess severity and facilitate appropriate mitigations to ensure compliance and continuous improvement.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
  • Must have expert GMP, Quality, and in-depth risk management knowledge.
  • Strong knowledge of core auditing processes
  • Broad knowledge of regulations in multiple GMP/GDP area(s); ability to translate regulations into operational requirements
  • Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
  • Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function.
  • Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Most have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking. Must possess an independent mindset and tenacity.
  • Knowledge of pharmaceutical products and processes

DUTIES AND RESPONSIBILITIES

General Responsibilities
  • Leads GMP/GDP audits of Celgene Contract Service Providers and Material Suppliers
  • Participates in the development and maintenance of department Standards, SOPs, and Guidance documents
  • Stays abreast of current global regulations
  • Participates in multi-disciplinary project teams as required
  • Provide input to the risk assessment of assigned auditable entities to identify the risk based audit frequency for each entity
  • Supports change control related to vendor status and maintains approved vendor lists or equivalent

Audit Preparation, Execution and Documentation
  • Consults with Business Owners, Quality Liaisons, audit teams and SMEs to ensure all potential risks are identified toward creation of audit agendas
  • Assures that audit reports are prepared and distributed in a timely manner per department procedure and metric goals
  • Assures reports and audit observations are consistent with procedural requirements
  • Immediately notifies management of potentially Critical Observations
  • Verifies audit responses are comprehensive and that appropriate corrective actions are taken to address observations.
  • Assures that post-audit activities (observation responses, response acceptance, audit certification and closure) are tracked and completed in a timely manner
  • Assures that all audit documentation is maintained in a compliant manner and is available for ready retrieval to support Business needs, regulatory inspection, etc.
  • Participates in completion of annual vendor risk assessments

Other Responsibilities
  • Provide front-room/back-room support during Health Authority Inspections as required
  • Performs other tasks as assigned

EDUCATION AND EXPERIENCE
  • Relevant college or university degree preferred. Equivalent combination of education and experience acceptable.
  • Minimum of 5 years relevant GMP/GDP pharmaceutical/biotechnology industry experience, including at least 3 years compliance related auditing experience.
  • CQA certification preferred.
  • Solid understanding of FDA and EMEA regulations is required. Knowledge of Anvisa regulations is helpful.
  • Ability to travel up to 40% as required.


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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.