Compliance, Senior Specialist

☞ KBI Biopharma

View: 247

Update day: 21-03-2024

Location: Plan-les-Ouates Genève GE

Category: Finance / Bank / Stock Sales

Industry: Biotechnology Research

Position: Associate

Job type: Full-time

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Job content

PositionSummary:
This individual will support compliance activities in a Contract Manufacturing Organization (CMO) setting at our Geneva Switzerland and Leuven Belgium sites. This individual is responsible for supporting client and internal audit programs, global risk management, management review, quality agreements and inspection readiness workstreams at KBI. This individual also implements change as required, to ensure compliance to cGMP requirements.
Position Responsibilities:
  • Support and client audit programs at local KBI sites. Coordinate client audit responses and ensure adequacy and appropriate corrective actions. Host client audits.
  • Support the internal audit programs at local KBI sites. Act as lead or support auditor, manage internal audit schedules.
  • Acting resource for execution of health authority inspections at KBI sites. Assist with preparation of inspections and/or responses to observations. Support inspection readiness workstreams and remediation activities to ensure site is inspection ready at all times.
  • Support site management review by obtaining and compiling data for quality system performance and improvements.
  • Support management of quality agreements by ensuring they are current and facilitating conversations with internal stakeholders.
  • Work with colleagues internally and at other KBI sites to ensure corporate compliance and implementation of corporate policies in site specific procedures.
  • Participate in special projects as needed.
Position Requirements:
  • BS and 8 (Senior) or 10+ (Principal) years experience or MS and 5+ years experience in a QA cGMP regulated environment.
  • Experience in auditing/inspection programs within regulated operations.
  • Experience managing and executing Quality Systems.
  • Additional experience in manufacturing, quality control, or technical operations within a regulated environment is required.
  • Fluent in French and English.
KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
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Deadline: 05-05-2024

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