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Remote Fda Auditor Jobs in Oregon (NOW HIRING)

A-dec, Inc.

Quality Assurance Specialist, Sr

Newberg, OR · Remote

$86K - $119K/yr

... FDA, Health Canada, and the European Union, via routine administration of processes, including ... Manages the internal audit process, leading audit teams and acting as a lead internal auditor, for ...

All JobsFda Auditor JobsRemote Fda Auditor JobsRemote Fda Auditor Jobs in Oregon

Remote Fda Auditor information

What are some common challenges faced by remote FDA auditors, and how can they be managed effectively?

Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.

What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?

AspectRemote Fda AuditorRemote Quality Assurance Specialist
CertificationsFDA auditor certification, GxP, GMP, GLPISO, Six Sigma, GMP, GCP
Work EnvironmentRegulatory agencies, pharmaceutical, biotech companiesManufacturing, clinical trials, healthcare companies
Industry UsagePrimarily in pharma, biotech, medical devicesBroader across healthcare, manufacturing, biotech

The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.

What is a remote FDA auditor?

Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.

What are the key skills and qualifications needed to thrive as a remote FDA auditor?

To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.
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Remote Fda Auditor jobs near you

Senior Counsel - Compliance

Mineralys Therapeutics

OR • Remote

$262K - $295K/yr

Full-time

Medical, Dental, Vision, Retirement

Re-posted 26 days ago

Job description

"Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone.  Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor.  Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky"

Mineralys is a fully remote company.

Senior Counsel - Compliance 

The Senior Director, Compliance will lead the design, implementation, and oversight of Mineralys' healthcare compliance program. This individual is accountable for establishing a scalable compliance framework that supports commercial launch readiness and ongoing business operations while ensuring adherence to applicable healthcare laws, regulations, industry standards, and company policies.

Operating in a fast-paced, pre-commercial biotech environment, this role requires a strategic compliance leader capable of partnering across Commercial, Medical Affairs, Regulatory, Finance, Human Resources, and Executive Leadership.

Key Responsibilities

  • Lead design and implementation of a scalable healthcare compliance program aligned with applicable laws, regulations, and industry guidance to enable commercialization success
  • Establish compliance governance, policies, procedures, standards, and risk management frameworks
  • Implement transparency and aggregate spend reporting processes
  • Proactively identify legal and compliance risks and develop practical mitigation strategies
  • Monitor evolving healthcare laws, regulations, and industry trends
  • Advise on compliance requirements related to HCP interactions, speaker programs, advisory boards, consultant engagements, grants, patient support programs, and medical education activities
  • Provide guidance regarding the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, PhRMA Code, and applicable state healthcare compliance laws
  • Develop and oversee compliance monitoring, auditing, and testing programs
  • Lead investigations of potential compliance concerns and oversee corrective and preventive action plans
  • Create and maintain compliance guidance documents, SOPs, and training materials
  • Oversee transparency reporting and related compliance obligations
  • Monitor regulatory developments, enforcement trends, and industry guidance and assess impact on Company practices
  • Collaborate with Legal, Regulatory, Privacy, Finance, and Human Resources teams on compliance governance initiatives

Qualifications

  • Bachelor's degree required; advanced degree preferred
  • JD, PharmD, MBA, MPH, or other relevant advanced degree preferred
  • 12+ years of pharmaceutical, biotechnology, or life sciences compliance experience
  • Significant experience building, implementing, or leading healthcare compliance programs
  • Expertise in healthcare compliance laws and regulations, including the Anti-Kickback Statute, False Claims Act, Sunshine Act, FDA requirements, and PhRMA Code
  • Experience supporting commercial launch readiness and commercial-stage operations
  • Experience conducting compliance risk assessments, investigations, monitoring, and auditing activities
  • Experience developing and delivering compliance training programs
  • Prior leadership experience within Compliance, Ethics, Legal, or related functions
  • Experience within a pre-commercial or emerging biotechnology company preferred

Core Competencies

  • Strategic and proactive compliance leadership with strong business acumen
  • Ability to influence senior leaders and drive a culture of ethics, integrity, and accountability
  • Strong risk assessment, problem-solving, and decision-making skills
  • Excellent communication and training capabilities
  • Ability to balance compliance oversight with business partnership
  • Demonstrated success operating in a lean, high-growth environment
  • Executive presence and ability to interact effectively with senior leadership and Board members

Travel

  • This position requires up to 10% travel. Frequently travel is outside the local area and overnight.

This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.

US Salary Range:  $262,022 - $295,584

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