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Quality Operations Manager

Quality Assurance | Research Triangle Park, NC | Full Time

Job Description

About Us:

Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.

Responsibilities:

  • The Manager of Quality Operations will have substantial quality and manufacturing experience
  • Oversees development and approval of cGMP documents including, but not limited to, SOPs, Technical documents, Batch records, protocols and specifications

  • Ensures all initial qualifications, validations, and re-validations are in place for facilities, equipment and processes related to research products manufacturing Ensures facilities are suitable for products manufactured. Review and approve documents related to validation

  • Ensures all non-conformances, OOS, deviations, complaints and related items are thoroughly investigated and resolved

  • Build Quality Systems related to materials management, disposition, SOP management

  • Ensures QA review of all manufacturing and QC related records, resolution of all related issues and QA disposition of product batches

  • Ensures QA review and disposition of raw materials, buffers and other components

  • Provides support to Quality Director on Quality and Compliance issues for Bioprocessing operations

  • Tracks KPIs, and Quality Risk Management program for Bioprocessing Operations.  Ensures escalation of quality issues to Site Quality Head as appropriate 

  • Support development and work with Quality team in gather data for annual Quality Management Review

  • Manages the Quality Operation teams and related GMP quality systems; trains, coaches and develops staff within Quality Operations team

Requirements:

  • Bachelors or Master’s Degree in: Pharmaceutical Technology, Biomedical Engineering, Biology or Chemistry

  • 8-10 years of pharmaceutical work experience, preferably in medical devices or biologics with 4 to 6 years of supervisory or management experience

  • Candidate will possess a demonstrated manufacturing and quality foundation in a pharmaceutical environment

Bonus Points:

  • Demonstrated background in support of pharmaceutical manufacturing and quality systems

  • Excellent written and oral communication skills 

  • Experience leading investigations, writing change controls and managing non-conformances

  • Background in one or more specialties of Pharmaceutical Technologies, Biology, Biomedical Engineering or Chemistry
  • Understanding of Quality Systems, Quality Operations and Manufacturing processes

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 3 Weeks’ Vacation
  • 5 Personal Floating Days
  • 8 Sick Days
  • 6 Company Holidays
  • Career Development and Training