Senior GCP Auditor

Job Title

Job Description

Senior GCP Auditor (EST or CST preferred)

The Senior GCP Auditor will help plan, coordinate, and execute clinical audits to assess clinical study compliance with Good Clinical Practice (GCP), regulatory standards, and study procedures.

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.

You're the right fit if:

• You’ve acquired 5+ years of relevant experience in the medical device industry with a masters’ degree OR 7+ years’ experience with a bachelor’s degree. Expert knowledge of CAPA, QMS, and GCP Audits (both internal and external).
• Your skills include strong knowledge of ISO 14155, ISO 13485, and GCP standards.
• You have a bachelor’s degree or higher required. Master’s degree or higher preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator with strong presentation skills. You are willing and able to travel up to 25%.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an field-based role.

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.

Learn more about our commitment to diversity and inclusion.

Philips Transparency Details

The pay range for this position in AZ, AR, ID, IA, KS, KY, LA, ME, MS, MO, NE, NM, OK, SC, SD, TN, UT, or WV is $122,906 to $196,650.

The pay range for this position in AL, CO, FL, GA, HI, IL, IN, MI, MN, NV, NH, NC, ND, OH, OR, PA, TX, VT, VA, WI, or WY is $129,375 to $207,000.

The pay range for this position in AK, DE, MD, NY, RI, or WA is $135,844 to $217,350.

The pay range for this position in CA, CT, DC, MA, or NJ is $144,900 to $231,840.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

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.

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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.