The Senior Clinical Quality Leader will play a critical role in ensuring Philips’ execution of clinical studies is conducted according to Philips requirements, applicable regulations, and guidance.Your role:
Provide leadership in execution of clinical studies to deliver high quality data to support Philips on time, within budget and in compliance with all applicable regulations and Philips procedures.
Drive adoption of compliant clinical study execution practices throughout Philips active clinical studies, including research and testing of products involving human beings.
Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
Support the clinical teams while acting as a Subject Matter Expert on clinical regulations, standards, and laws.
Support, update, and maintain the Clinical Trial Management System application for clinical study execution and reporting.
Develop and deliver clinical research focused trainings to many different audiences.
Support CAPA and Root Cause Analysis work on Clinical CAPAs in a timely and effective manner.
This Hybrid role may require travel up to 10%.
You're the right fit if:
You’ve acquired a minimum of 7+ years’ experience working in FDA regulated Clinical Study environments, with a focus on Clinical study execution, policies, and procedures.
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 expertise in clinical regulations, standards, and laws.
You have detailed knowledge of compliant Clinical Operations policies and procedures.
You have excellent presentation skills and the 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 (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
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 (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-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 (https://www.careers.philips.com/global/en/diversity-and-inclusion) .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-PH1It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
