Sr. Manager, 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 Senior Manager, GMP/GDP Audit 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. Responsible for vendor lifecycle management for GMP/GDP vendors.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
- Must have expert GMP, Quality, and risk management knowledge.
- Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
- Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.
- Must drive development of technical or scientific initiatives by interdisciplinary teams.
- Must have expert authorship in technical documents. Must be able to critically interpret results and generate technical conclusions consistent with Quality risk principles.
- Must have expert authorship in audit reports, investigations, quality agreements, and risk assessments. Must be able to critically interpret results and determine the desirability of new or additional content for GMP policies and standards, etc.
- Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation. Must possess authenticity.
- Knowledge of pharmaceutical products including biologic and/or cell therapy products.
DUTIES AND RESPONSIBILITIES
- Leads a team of auditors actively managing departmental operations
- Develops department training plan: trains and develops junior staff
- Develops, implements and maintains department Standards, SOPs, and Guidance documents
- Stays abreast of current global regulations; updates SOPs and Guidance documents as required
- Acts as a mentor to junior staff
- Leads or participates in multi-disciplinary project teams as required
- Will participate in, lead and/or observe audits as required to meet audit schedules, assure consistent department performance and assess junior staff
- Provide input to the risk assessment of assigned auditable entities to identify the risk based audit frequency for each entity
- Provide input to and coordinate annual/quarterly audit schedules with the Director of GMP/GDP Compliance; assures execution of all required audits
- Participates in the development, qualification and maintenance of electronic solutions supporting the audit program
- Supports change control related to vendor status and maintains approved vendor lists or equivalent
Audit Preparation, Execution and Documentation
- Assures that Lead Auditors consult 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
- Reviews staff reports for consistency with procedural requirements and calibration of observation criticality
- Assures that potentially Critical Observations are escalated to senior management
- Organize meetings with applicable Executive Quality Director, Business Owner, Legal, Global Compliance and others to discuss critical or major findings and potential impacts
- 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.
- Assures 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 required; advanced degree preferred
- Minimum of seven years of relevant GMP/GDP pharmaceutical/biotechnology industry experience, including at least 5 years of Compliance related auditing experience.
- Experience with pharmaceutical products including sterile, biologic and/or cell therapy products.
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.
Celgene 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.