Immunomedics, Inc.

Senior GMP Compliance Specialists

Job Locations US-NJ-Morris Plains
Posted Date 2 months ago(4/5/2020 2:22 PM)
Job ID
2020-1663
# of Openings
1
Category
GxP Quality & Compliance

Overview

Reporting to the Associate Director, Quality Compliance, the Senior GMP Compliance Specialist will play a critical role in in ensuring a continuous and sustainable state GMP compliance, through internal audit, monitoring, and oversight of self-inspection programs.  This position will assist in ensuring all GMP personnel remain complaint with applicable regulatory requirements and Immunomedics policies and procedures, in support of Immunomedics clinical/commercial products.  This includes ensuring there is appropriate training and consistent data integrity and compliance.   

Responsibilities

  • Lead Internal Audits, as outlined in the yearly audit plan, escalating compliance concerns to Sr. Management as necessary.
  • Assist in facilitation of the Immunomedics Quality Policy.
  • Conduct regular facility walkthroughs to assess area compliance to site procedures and applicable external regulations and standards.
  • Ensure effective implementation of CAPAs, mitigation/remediation plan(s) and ensure a continuous state of inspection readiness.
  • Track and trend Self Inspection and Internal Audit observations and responses to successful closure.
  • Prepare and provide on-site support to Immunomedics sites for regulatory inspections and third-party audits as needed. Provide front and back room support.
  • Facilitates transparency and communication of lessons learned and best practice sharing across the organization.
  • Develops tools for implementation of an effective self-inspection program with training across organizations
  • Develops and performs effectiveness checks of all self-inspection programs.
  • Perform compliance investigations as needed, provide support and review complex investigation reports of non-compliances in GMP areas.
  • Conduct and support pre-approval / pre-submission project reviews, mock inspections and inspection readiness assessments.
  • Ensure Good Documentation Practices (ALCOA) are followed, through regular compliance oversight of documentation and data.
  • Understand and apply global regulations to processes to ensure compliance.
  • Create, review and/or approve appropriate policies, directives and procedures in alignment with relevant governmental regulations and guidelines.
  • Provide active participation during regulatory agency inspections, as needed.
  • Perform other related tasks and assignments as needed and specified by management related to document generation and control.
  • Assist in BLA and other submission data verification reviews, as applicable.  

Qualifications

  • Minimum of a Bachelor’s degree in a Technical/Science related field (e.g. Biochemistry, Engineering, Chemistry, Biology, etc.)  or equivalent is required; with 6-8+ years of experience in the biotechnology, pharmaceutical, (GxP) industry; or equivalent combination of education and experience. 
  • Technical knowledge of Manufacturing, Facilities, Equipment, and/or Laboratory procedures/processes in the Biologics space is preferred.
  • GMP Audit experience.
  • Take a proactive approach to continuous improvement based on data, trends and outcomes of management reviews.
  • Excellent written and verbal communication skills required, including responsible business communication.
  • Comfortable with ambiguity and can adapt style and tactics based on situation.
  • Focus on achieving objectives within specified timeframe and to meet quality expectations.
  • Knowledge of relevant GMP regulations and guidance to include but not limited to 21 CFR, ICH, EU GDP/GMP, PIC/S.  
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with all MS Office applications.
  • Ability to work independently and to make decisions based on experience.

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