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Full-Time

Associate Director

GCP Quality and Compliance

Confirmed live in the last 24 hours

PFM

PFM

501-1,000 employees

Financial services for asset management and advisory

Consulting
Fintech

Compensation Overview

$125.2k - $187.8kAnnually

+ Bonus

Senior, Expert

Remote in USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Management
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
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.
  • Other duties as assigned

PFM provides a variety of financial services, focusing on asset management, financial advisory, and consulting. The firm helps clients, including governments, educational institutions, and non-profits, plan for their financial futures through services like investment advice and retirement planning. PFM tailors its solutions to meet the specific needs of its clients, which allows them to effectively manage assets and navigate complex financial situations. Unlike many competitors, PFM has a strong emphasis on public finance and offers specialized teams for areas such as transportation finance and economic consulting. The company's goal is to deliver customized financial strategies that address the unique challenges faced by their diverse clientele, while also providing ESG solutions for sustainable investments.

Company Stage

Grant

Total Funding

N/A

Headquarters

Philadelphia, Pennsylvania

Founded

1975

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

-2%

2 year growth

-2%
Simplify Jobs

Simplify's Take

What believers are saying

  • PFM's national recognition and expertise in public finance make it a trusted partner for clients seeking specialized financial advice.
  • The recent acquisition by U.S. Bancorp Asset Management could provide additional resources and growth opportunities for PFM.
  • Partnerships like the one with Sodaclick for AI-powered ordering systems demonstrate PFM's commitment to innovation and expanding its service offerings.

What critics are saying

  • The integration with U.S. Bancorp Asset Management may pose challenges in aligning corporate cultures and operational processes.
  • The competitive landscape in financial services requires PFM to continuously innovate to maintain its market position.

What makes PFM unique

  • PFM's specialization in public finance sets it apart from competitors who may not have the same depth of expertise in this sector.
  • The company's comprehensive service offerings, including ESG solutions and specialized transportation finance, provide a unique value proposition.
  • PFM's client-focused approach and tailored financial solutions ensure that they meet the specific needs of diverse clients, from local governments to non-profits.