Principal Specialist, GMP/GDP Audits
Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
PURPOSE AND SCOPE OF POSITION
The position is responsible for GMP/GDP audits of vendors and internal sites, 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
- 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
- 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.
Up to 50% travel required
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.