Quality Assurance Director

3 weeks ago

Germantown, Maryland, United States uBriGene Biosciences Full time
Job Title: QA Director

At uBriGene Biosciences, we are seeking a highly skilled and experienced QA Director to lead our quality assurance program.

Job Summary:

The QA Director will be responsible for overseeing and coordinating our QA program, ensuring compliance with regulatory requirements, and promoting a culture of quality within the organization.

Key Responsibilities:
  1. Quality System Development: Build and maintain a robust quality system that meets FDA requirements.
  2. Customer Support: Serve as the primary QA contact for internal and external customers, providing guidance and support as needed.
  3. Policy Development: Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation and recommendations to regional or Global QA Management.
  4. Critical Issue Management: Provide Quality Assurance support, guidance, and management of critical Quality Issues, as assigned.
  5. Regulatory Compliance: Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
  6. QA SOP Development: Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce.
  7. Audit Management: Host customer audits and participate in review of corrective action plans, as assigned.
  8. Regulatory Inspections: Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned.
  9. Audit Planning and Reporting: Plan, schedule, conduct, report, and close audit activities, as assigned.
  10. Compliance Management: Oversee documentation, reporting, and closure of compliance issues.
  11. Quality Metrics: Support Quality Management in proposal reviews and reporting QA metrics.
  12. Trend Analysis: Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned.
  13. Special Projects: Participate in or lead (cross-functional) teams for special projects as assigned.
  14. Quality Promotion: Promote the concept of quality, the principles of quality management, and devise and implement quality improvements.

Qualifications:

  1. Education: At least a Bachelor's Degree.
  2. Experience: years of Quality Assurance experience in pharmaceutical, technical, CDMO, or related areas.
  3. Technical Skills: Knowledge of word-processing, spreadsheet, and database applications.
  4. Regulatory Knowledge: Strong knowledge of pharmaceutical research and development processes and regulatory environments.
  5. Quality Assurance Knowledge: Considerable knowledge of quality assurance processes and procedures.
  6. Interpersonal Skills: Strong interpersonal skills and the ability to positively influence and guide others.
  7. Problem-Solving Skills: Excellent problem-solving, risk analysis, and negotiation skills.
  8. Leadership Skills: Effective organization, communication, and team orientation and leadership skills.
  9. Audit Experience: Possess applicable experience in conducting audits, writing audit reports, and analyzing audits.
  10. Leadership Experience: Demonstrated ability to lead and manage multiple responsibilities.
  11. Functional Analysis: Identify functional constraints and identify solutions.
  12. Time Management: Ability to coordinate timelines with internal customers and external vendors.
  13. Activity Management: Ability to manage multiple activities and timelines.
  14. Departmental Needs: Ability to articulate and define departmental needs and processes.
  15. Relationship Building: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

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