Senior Good Clinical Practice

1 month ago

Pittsburgh, Pennsylvania, United States Philips Full time
Job TitleSenior Good Clinical Practice (GCP) AuditorJob Description

The Senior Good Clinical Practice (GCP) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with Internal/External regulatory and quality standards.

Your role:

  • Executing & leading Good Clinical Practice (GCP) audits in line with defined methodology.
  • Planning, coordinating, and executing clinical audits to assess clinical study compliance with Good Clinical Practice (GCP), regulatory standards, and study procedures.
  • Further refining the scope of audits, and executing document reviews, data analytics and interviews.
  • Writing the audit reports, documenting the findings, preparing audit risk profiles, and evaluating risk & controls in types of audits.
  • Engaging with auditees on reporting audit outcomes and recommendations.
  • Participating in developing audit plans based on risk profiles.
  • Dealing effectively (with decisiveness, diplomacy, empathy, and care as required) with escalations and customer complaints during an audit.
  • This role may require travel up to 25%.

You're the right fit if:

  • You've acquired a minimum of 7+ years' experience working in FDA regulated Quality Management Systems (QMS)/Clinical environments, with a minimum of 3 years focused on GCP Audit.
  • You have current certification (s) with a recognized accreditation body (i.e. RAB- QSA/IRCA) OR one of the following (preferred): Successful completion of ASQ certification as a Certified Quality Auditor (CQA) and/or Certified Biomedical Auditor (CBA), Successful completion of a Lead Auditor Course.
  • You have expert knowledge of applicable regulations/standards training (i.e. ICH, ISO 14155, ISO 13485, 21CFR820, 21CFR812...)
  • You have expert CAPA Knowledge and experience.
  • You have excellent presentation skills and an ability to effectively communicate clinical trial outcomes to disparate audiences.
  • You have a minimum of a Bachelor's Degree in Clinical/Health Sciences or related disciplines (Required), Masters or advanced degree desired.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our employee benefits.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details:

The pay range for this position is $116,000 to $199,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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