Full-Time

Associate Director

GCP Quality and Compliance

Posted on 10/24/2024

PFM

PFM

501-1,000 employees

Financial services for asset management and advisory

Consulting
Financial Services

Compensation Overview

$125.2k - $187.8kAnnually

+ Bonus

Senior

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Google Cloud Platform
Excel/Numbers/Sheets
Requirements
  • Requires 8-10 years of experience in clinical research or pharmaceutical development with emphasis in Quality Assurance/Compliance or equivalent relevant experience and/or demonstrated competencies
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards
  • Bachelor’s degree in a science, healthcare or related field of study
  • Availability to travel up to 25% domestically and/or internationally
  • Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, computer skills
  • Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs
  • Advanced proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
  • Has basic understanding of financial management to review proposals and budgets
  • Fluent in English language
Responsibilities
  • Work closely with the Quality and Compliance management/staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials and performs ICH/GCP quality reviews/audits to ensure overall compliance with applicable regulations.
  • Lead the oversight of a Quality Management Systems inclusive of SOPs, Training and CAPAs.
  • Support and mentor Quality & Compliance team members.
  • Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g. MHRA).
  • Provide ICH/GCP guidance, auditing advice and training to internal and external clients.
  • As part of the Management Team help counsel on and direct quality initiatives to Provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally.
  • Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises.
  • Lead system, site, documentation & Trial Master File audits to ensure compliance with internal SOPs/project plans and industry standards.
  • Review/audit documents intended for submission to the FDA to assure compliance with regulatory standards.
  • Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients.
  • Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine.
  • Maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams.

PFM offers financial services including asset management, financial advisory, and consulting, primarily for public sector clients like governments and educational institutions. Their services help clients with investment advice, financial planning, and retirement planning, tailored to meet specific needs. PFM stands out from competitors with its deep expertise in public finance and a client-focused approach, providing specialized teams for areas like transportation finance and economic consulting. The company's goal is to be a trusted partner in the public finance sector, assisting clients in navigating complex financial landscapes.

Company Stage

Acquired

Total Funding

N/A

Headquarters

Philadelphia, Pennsylvania

Founded

1975

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Simplify's Take

What believers are saying

  • Growing demand for ESG solutions boosts PFM's sustainable investment offerings.
  • Public-private partnerships create new opportunities for PFM's transportation finance team.
  • Digital advisory platforms expand PFM's reach and complement traditional services.

What critics are saying

  • AI-driven advisory services threaten PFM's traditional business model.
  • U.S. Bancorp's acquisition may affect PFM's operational independence and client trust.
  • Failure to meet ESG standards could harm PFM's reputation in sustainable investing.

What makes PFM unique

  • PFM specializes in public finance, serving diverse clients like governments and nonprofits.
  • PFM offers tailored financial solutions, including ESG and transportation finance expertise.
  • PFM's client-focused approach ensures customized financial strategies for unique client needs.

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Benefits

Health Insurance

Life Insurance

Disability Insurance

Parental Leave

Paid Vacation

Paid Sick Leave

Performance Bonus

INACTIVE