- 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'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, 21CFR
- 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.
- 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.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
-
Senior Clinical Quality Leader
2 weeks ago
Philips Bothell, United StatesJob Title · Senior Clinical Quality Leader · Job Description · 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: · * Pr ...
-
Senior Clinical Quality Leader
3 weeks ago
Philips Bothell, United StatesJob Title · Senior Clinical Quality Leader Job Description · 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: · Pr ...
-
Manufacturing Associate
3 weeks ago
Actalent Bothell, United States Full timeDescription: · We are seeking a Manufacturing Associate I to participate in cGMP activities in the cGMP production facility. The Associate will use their training and knowledge of biopharmaceutical manufacturing to execute operations in a cGMP facility. · • Primary areas of respo ...
-
Manufacturing Associate
2 weeks ago
Actalent Bothell, United States Full timeDescription: · POSITION SUMMARY: · The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. Shift Schedule: W ...
-
Manufacturing Associate
2 weeks ago
Actalent Bothell, United States Full timeDescription: · The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. This role is responsible for performing day to day operations. · KEY ROLE AND RESPONSIBILITIES: · ...
-
Omega Ventures Bothell West, United StatesJob in Bothell West: Your Responsibilities * Assumption of technical leadership and coordination of the electrical planning team in the absence of the regular group leader * Execution of electrical planning work for intralogistics systems * Creation of electrical diagrams, circui ...
-
Warehouse management
3 days ago
Infinity Systems Kenmore, WA, United States Freelance**The NORDFROST Group is Germany's market leader in frozen logistics. As a family-owned company with its headquarters in Schortens, near Wilhelmshaven in northern Germany, we operate 40 temperature-controlled logistics sites with around 3,000 employees and maintain a nationwide a ...
-
Team Leader Housekeeping
3 days ago
Neptune Enterprises Maltby, WA, United States Freelance**Housekeeping Team Leader (m/f/d) in Maltby, WA** · **Become a hero today - apply now** · We are looking for a Housekeeping Team Leader (m/f/d) to join our team at our holiday village, initially on a fixed-term contract for 2 years. · **Your responsibilities:** · - You enjoy org ...
-
Specialist Quality Management
3 days ago
Apex Ventures Maltby, WA, United States Freelance**Reference number**: 40414 · Döhler is a global leader in the production, marketing, and supply of technology-based natural ingredients, ingredient systems, and integrated solutions for the food and beverage industry. We offer our customers a wide range of natural flavor, textur ...
-
Apex Ventures Clearview, WA, United States Freelance**Dear applicants,** · We want our residents to never lose sight of the beauty in life, even as they age. Our goal is to provide them with a life of independence, offering everything they need for their personal well-being. · Recognizing the needs of our residents and maintaining ...
-
Youth Sports Coaches
5 days ago
Skyhawks Sports Academy Shoreline, United States**Job description** · **Benefits/Perks** · - _Entry-level Program Coach roles available_ · - _Program Director roles available to those looking to grow as leaders_ · - _Work with kids in sports - The best job you will ever have_ · - _Varied work locations throughout your communit ...
-
Landscaping Technician
3 days ago
Ballinger Landscaping Shoreline, United StatesDo you enjoy working outside, with your hands? Are you looking for independence and a chance to learn and grow with a smaller company? Do you want individual responsibility, while working as part of a team? · Ballinger Landscaping is a local leader in providing residential and co ...
-
Logistician (m/f/d)
3 weeks ago
Apex Dynamics Silver Firs, United StatesCommitted to Research. Dedicated to Patients. · With over 120 years of experience and more than employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and providing new treatment standards that improve quality of life worldwide. · In Europe, we fo ...
-
Training as a Machinist
2 days ago
Sapphire Solutions Picnic Point, United StatesApprenticeship as Machinist (Turning, Milling, or Grinding Machine Systems) (m/f/d)The Apprenticeship · As part of this comprehensive apprenticeship at a globally active innovation, quality, and market leader in the transportation industry, you will gain deep insights into the pr ...
-
Employee for tool preparation
2 days ago
FusionTech Lake Stickney, United StatesAbout the Company · Since 1904, our more than 300 employees at 5 production sites in Germany and the USA have made us what we are today: the market leader in high-quality molded foam parts. Our customers appreciate us for optimized packaging solutions for household appliances, in ...
-
Team Leader R&D
3 weeks ago
Crimson Solutions Lake Stickney, United StatesMIWE makes baking easy. With over 700 employees, we develop and manufacture everything that makes the life of a baker easier at two locations in Germany - from compact baking stations to large industrial ovens, from sophisticated climate and refrigeration technology to fully auto ...
-
Software Engineer
2 weeks ago
WALGREENS Bellevue, United States Full timeSoftware Engineer (JavaScript, React, Java, Python) · Job Summary · This role performs and implements activities that impacts components / processes of specified functional areas of the Walgreens business software products OR Digital/Online application in an Agile environment. Wo ...
-
Software Development Engineer
2 weeks ago
WALGREENS Bellevue, United States Full timeJob Summary · This role performs and implements activities that impact components / processes of specified functional areas of the pharmacy platform operation in an Agile environment. Work is typically received in short term assignments that require application of independent jud ...
-
Software Engineer
2 weeks ago
WALGREENS Bellevue, United States Full timeFrontend Software Engineer (JavaScript, React, DevOps) · Job Summary · This role performs and implements activities that impacts components / processes of specified functional areas of the Walgreens business software products OR Digital/Online application in an Agile environment. ...
-
Senior Software Engineer
2 weeks ago
WALGREENS Bellevue, United States Full timeJob Summary: · Seasoned, experienced professional with a full understanding of area of specialization, who will perform and implement activities that impact components / processes of specified functional areas of the Walgreens Software applications. Anticipates and prevents probl ...
Senior Clinical Quality Leader - Bothell, United States - Philips
Description
Job TitleSenior Clinical Quality LeaderJob Description
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.
Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.Your role:
You're the right fit if:
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.
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.
PDN-9bc9574a-aadc-488d-a192-e1d2ba5a32e0