jobs

Quality Manager

Pneuma Respiratory
Boone, NC Full-time
Posted on August 25, 2019

Quality Manager – Boone, North Carolina

Job Purpose: This position contributes to the Company’s success by managing the cGMP quality systems required to monitor the quality of third-party contract manufacturing organizations (CMOs) throughout the entire product lifecycle.

Top Reasons to Work for Us

  1. Competitive Salary
  2. Company pays 100% of health insurance
  3. Stock option grants
  4. Help build life changing technology

Required Qualifications and Skills:

  • Bachelor's degree in scientific / technical discipline
  • 3+ years’ experience in the Biotechnology / Biopharmaceutical / Pharmaceutical industry with pharmaceutical or medical device products intended for human use
  • 5+ years’ experience working in progressively responsible positions in Quality Assurance, including final closure review of deviation / non-conformance investigations and batch disposition determination
  • Experience interfacing with regulatory agencies (g., FDA)
  • Strong analytical experience preferred
  • Strong understanding of GMP, including 21 CFR 210 and 211, ICH guidelines and FDA requirements for pharmaceuticals
  • Experience with CMO, CTL and packaging / labeling
  • Strong organizational skills, conscientious in attending to detail
  • Excellent written and verbal communication skills
  • Demonstrated analysis and problem-solving skills
  • Ability to work in a dynamic, fast-paced environment with shifting priorities
  • Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro

Summary of Key Responsibilities:

  • Manage all aspects of quality systems, such as change control, deviations, investigations, complaints and CAPA systems to assure compliance and timely and accurate completion of reported events
  • Manage Company's Quality Compliance in maintenance of site training, supplier management, internal audits and related functions
  • Contribute to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and Company quality standards in support of cGxP activities
  • Manage the QA batch release function for cGMP commercial manufacturing and distribution activities from the CMO facilities
  • Contribute to preparation and/or review of annual product review and updates for regulatory filings, batch release metrics and department reporting, as applicable
  • Participate in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects
  • Prepare and/or review controlled documents (g., SOPs) required for compliance

Other duties as assigned by manager

Job Type: Full-time

Experience:

  • Biotechnology / Medical Device / Pharmaceutical industry: 7 years (Preferred)
  • Quality Assurance: 5 years (Required)

Work authorization:

  • United States (Required)