Job Title

Job Description

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today, Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

You are responsible for

• 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

You are part of

The Chief Medical Office, reporting to our Director of Clinical Quality and Audit. The Clinical Quality and GCP Audit function reports into our Head of Global Clinical Operations, Quality and Compliance.

To succeed in this role, you’ll need a customer-first attitude and the following

• Minimum of BS/BA and Advanced Degree in Health Sciences related field preferred
• Current certification 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
• 10+ years’ experience in a regulated industry (preferred)
• 8+ years working in the area of quality management systems and/or GCP / Clinical Research with a minimum of 3 years’ experience in GCP Audit
• Expert knowledge of applicable regulations/standards training (i.e. ICH, ISO 14155, ISO 13485, 21CFR820, 21CFR812…)
• Expert CAPA Knowledge and experience
• Must have excellent presentation skills and an ability to effectively communicate clinical trial outcomes to disparate audiences
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

In return, we offer you

The ability to collaborate with, learn and grow from colleagues in a highly complex, global organization where you can use your strengths to help drive strategic business initiatives for Philips. Additionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

• Montana employees are currently excluded from this requirement at this time.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

How we work at Philips

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.

We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

#LI-PH1

#LI-Remote

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