Head of QA Ops, APU 11 Forbes

About the role

The Head of Quality Assurance Operations is responsible for overseeing and managing all quality and compliance activities within the manufacturing facility, ensuring compliance with regulatory requirements, GMP standards, and organizational quality objectives. This role plays a critical part in maintaining product quality, driving continuous improvement, and leading a high-performing Quality team.

Responsibilities

• Batch Review & Disposition: Review and prepare batch disposition for all intermediates and finished goods manufactured within the assigned area. Final accountability resides under the QAP (Qualified Authorized Person, or equivalent) depending on local regulations.

• Regulatory Readiness: In case of specific regulations linked to the area (e.g., Device, MTI), ensure readiness for inspection by national and international agencies through implementation of corresponding specific requirements.

• Annual Quality Objectives: Develop and implement annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives.

• Quality Procedures: Develop and implement quality operation procedures supporting the proper execution of manufacturing activities.

• Compliance & Risk Management: Maintain a system to ensure compliance and quality risks are properly identified, tracked, and mitigated.

• Quality Event Closure: Ensure the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency.

Qualifications

• Basic Requirements:

  • Bachelor's Degree in Life Sciences or related fields with 10+ years of experience in quality assurance within the pharmaceutical industry
  • Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
  • Experience in Drug Product Manufacturing
  • Ability to analyze complex data and identify trends, issues, and solutions
  • High level of accuracy and attention to detail in all quality assurance activities
  • Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

• Expected Technical Skills:

  • Inspection Management Experience at a Drug Product Manufacturing Site
  • Proficiency in identifying problems and implementing effective corrective actions
  • Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
  • English proficiency required.