Quality Systems Compliance Manager

Johnson & Johnson   •  

Palm Beach Gardens, FL

Industry: Biotech/Pharma

  •  

8 - 10 years

Posted 297 days ago

This job is no longer available.

Position duties & responsibilities:

  • You'll direct and conduct internal and external audits against QSReg and ISO.
  • Lead site specific audit readiness activities.
  • Provide audit results to management and coordinate audit CAPA/OBS actions.
  • Direct or conduct personnel training on FDA and ISO requirements.
  • Review and approve all site and applicable corporate SOPs, WIs, etc.
  • Direct and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues.
  • Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements. Monitor external publication sources for issues applicable to DePuy Synthes.
  • Provide consulting service to site and corporate personnel.
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
  • Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.
  • Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
  • Perform all other duties as assigned.

Qualifications

  • Minimum of 8 years quality/compliance experience in the medical device and/or pharmaceutical/highly regulated industry.
  • Direct contact/interaction experience with the FDA, ISO registrars and other notified bodies is required
  • A minimum of 3 years’ experience directly performing audits in the medical device and/or pharmaceutical/ highly regulated industry is required.
  • Experience working with Manufacturing, Product Development and Corporate functions is preferred.
  • This position will be based in Palm Beach Gardens, FLA and requires up to 15% travel.
  • EDUCATIONAL REQUIREMENTS:
  • Bachelor degree in science, engineering, quality or other technical field.
  • Auditor Certification, such as ASQ CQA, is preferred.
  • Documented training in FDA Quality System Regulation (QSReg), ISO 13485 and MHLW Ordinance 169.

Requisition ID: 9564170901