Quality Assurance Manager
Updated on 2/3/2024
PFM

501-1,000 employees

Provides financial advisory and strategic consultation services
Company Overview
PFM stands out as a leading financial advisory firm due to its commitment to providing tailored, creative consultation that goes beyond traditional financial advice, empowering and educating its clients for sustainable outcomes. The company's competitive edge lies in its diverse range of services offered through affiliated entities, all under the PFM brand, including financial advisory, swap advisory, consulting, strategic forecasting, and a web-based platform for municipal bond information. PFM's industry leadership is further demonstrated by its adherence to regulatory standards, with registrations with the SEC, MSRB, and the Commodity Futures Trading Commission.
Consulting

Company Stage

Grant

Total Funding

N/A

Founded

1975

Headquarters

Philadelphia, Pennsylvania

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

-22%
Locations
Winston-Salem, NC, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
CategoriesNew
QA & Testing
Requirements
  • Bachelor’s Degree in Physical, Biological Sciences, or technical/scientific field
  • 5 – 8 years of experience as a Quality professional in the biotechnology or life science, regulated environment
  • Successful ISO13485 accreditation and 21 CFR Part 820
  • First-hand experience with Design Control and associated Design History File and supporting post-market effort surveillance
  • Excellent knowledge of medical research processes, laboratory testing protocol, and safety requirements
  • Strong understanding of medical data collection, record keeping, and reporting requirements
  • Experience interpreting and complying with worldwide cGxPs with an emphasis on CAP/CLIA, GMP, GCP, GLP, GCLP, and ISO 15189
  • Experience auditing and interacting and relationship building with the public (vendors and clients)
  • Proficiency with common computer applications such as MS Office and other relevant industry computerized systems
  • Extended business hours may be necessary in order to meet the business demands
  • Occasional domestic or international travel, including overnight stays (up to 20%)
  • Must possess a valid driver’s license allowing you to drive in the state(s) you drive in
  • Must be able to read, write, speak fluently and comprehend the English language
Responsibilities
  • Collaborate with operational and quality staff in other Precision locations to execute harmonization plans for global processes and procedures
  • Plan and direct resources to manage the quality assurance and compliance functions in conjunction with the Director Quality Assurance
  • Responsible for aligning global practices, promoting improvement, leading and maintaining compliance, and measuring and reporting on performance and effectiveness through established metrics and KPIs
  • Lead inspection readiness activities
  • Host external client audits in addition to assessments and inspections conducted by regulatory agencies and notified bodies
  • Manage the Quality System and support the quality functions of all critical operations
  • Create/revise/coordinate-controlled document system
  • Review and approve quality system activities
  • Contribute to the evaluation and mitigation of program risks and escalation of potentially significant quality issues
  • Participate in cost reduction and improvement programs
  • Support the training program by promoting training activities related to operations, quality assurance, Safety, and compliance
  • Maintain an up-to-date knowledge in the techniques of quality and in the company products/services and process technologies
  • Responsible for ensuring management reviews of the quality system are conducted
  • Maintains up-to-date knowledge of regulations and applicable worldwide standards and requirements
  • Participate actively as a permanent safety committee member
  • Schedule and manage the review of computer systems, process and equipment validations and re-validation in accordance with established Company policy
  • Work in conjunction with purchasing department to develop supplier partnership opportunities and ensure supplier qualifications meet current Quality Standards and regulatory requirements
  • Other duties as assigned
Desired Qualifications
  • Master’s degree in Physical, Biological Sciences, or technical/scientific field
  • ASQ or SQA certification