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Head of Quality

4 months ago

Durham, United States BiotechPharma Full time

The Head of Quality at is primarily responsible for managing the project review activity within the Quality Assurance & Quality Control team, ensuring that all project work is assigned and completed per SOPs and applicable regulations, and is completed per agreed delivery due dates. The Head should be familiar with and have hands-on experience with MDI, Topical & Transdermal dosage forms. The Head will ensure that all site projects have an assigned QA & QC rep who will be responsible for all aspects of the project, including document and report review, investigations, deviations, and CAPAs.


The Head will also be responsible for managing the QA & QC Specialists, and for ensuring that other QA & QC tasks as outlined below are assigned and managed within the teams. Finally, the Head of Quality will be responsible for inputting improvements and direction of the QA & QC functions.


Position Description:

  • Perform managerial duties as required, e.g. 1:1s with direct reports, personnel development plans, and performance appraisals, ensure that company policies are adhered to, plan department meetings, represent the company in the role as manager and continuously inform employees as relevant;
  • Ensure QA team responsibilities (project work, method transfer and validation support, calibration/OOT, archiving, ELNBs, Key Supplier management, SOPs, investigations, deviations, change controls, instrument validation) are assigned and managed to completion per due dates;
  • Input into the structure and responsibilities of the QA function, suggesting improvements to processes and procedures for the Quality Assurance function in close collaboration with other groups and departments in the Company;
  • SME for tech transfer protocols for adherence with ICH requirements, and appropriate test plans and acceptance criteria are applied;
  • Review and approve project requirements and deliverables for assigned projects, including protocols and test methods, Validation/Method Transfer Reports, Certificates of Analysis and Stability Reports;
  • Assist hosting customer audits and regulatory inspections, acting as SME for project activities audited, including managing QA responses;
  • Work closely with Senior Management, Managers, and Technical Leads for fast-moving projects to ensure proper and timely communication and delivery. Follow up on adherence to budget for the QA tasks;
  • Ensure the QA training program is robust and provide staff with appropriate training materials and requirements and provide routine QA training to the site’s lab staff and other staff as needed;
  • Contribute to SOP updates for the site, and assisting in Internal Audits on site;
  • Serve as subject matter expert for group activities and responsibilities both with site customers and during audits and inspections;
  • Other responsibilities as assigned;


Other:

  • Provide consultation to company personnel on QA-related matters, which may require in-depth evaluation of various factors;
  • Meeting personal and company deadlines and deliverable due dates;
  • Adhere to SOPs and GMP/GLP/Safety requirements;
  • Maintain a safe and clean working environment.


Qualifications:

  • Master’s Degree/Four-year degree in Chemistry or Pharmaceutical Sciences, or related experience, and around 20 years of experience in a pharmaceutical environment in a Quality-related field;
  • Good working knowledge of computers and programs such as MS Word and Excel, PowerPoint, and making trend data sheets;
  • Must possess a thorough understanding of laboratory procedures and a strong knowledge of relevant cGMP requirements;
  • Ability to build relations and interact effectively.