Head of Quality Assurance

3 weeks ago

United Kingdom AssureBio Full time

AssureBio has an opportunity for an experienced Head of Quality to join our clients growing team. The primary responsibility of the Head of Quality is to ensure the safety of end-users by maintaining rigorous regulatory compliance. This includes designing, implementing, monitoring, and maintaining the quality management system, managing licenses for specials manufacture, and overseeing Competent Authority inspections and customer audits. The role also involves leading the QA team to meet its objectives.

Key Responsibilities

  • Oversee all quality aspects within the compounding unit.
  • Approve or reject starting materials, packaging materials, intermediates, bulk, and finished products as necessary.
  • Ensure comprehensive testing and record evaluation.
  • Approve specifications, sampling instructions, test methods, and other quality control procedures.
  • Monitor and approve any contract analysis.
  • Ensure the qualification and maintenance of premises and equipment in the compounding unit.
  • Ensure appropriate validations are conducted.
  • Oversee the initial and ongoing training of department personnel, adapting as needed.
  • Authorize written procedures and other documents, including amendments.
  • Monitor and control the manufacturing environment, plant hygiene, process validation, training, and approval/monitoring of suppliers and contract manufacturers.
  • Monitor storage conditions and retention of records for materials and products.
  • Ensure compliance with Good Manufacturing Practice (GMP) requirements.
  • Conduct inspections, investigations, and sampling to monitor factors affecting product quality.
  • Lead management reviews of process performance, product quality, and the quality management system, advocating for continual improvement.
  • Establish a timely and effective communication and escalation process for quality issues.
  • Provide technical and professional guidance for compounding services, ensuring continuity of patient care.
  • Review, develop, and implement a strategic vision and delivery plan for compounding unit services.
  • Provide professional leadership and management of staff to achieve high standards of pharmaceutical care, ongoing training, and effective empowerment.
  • Act as Head of Quality Control for the compounding unit Specials Manufacturing Licence.
  • Eligible to act as a Releasing Officer named in the unit’s Quality Management System (QMS).

Experience and Qualifications

  • Proven experience managing a QA function in a manufacturing unit and hosting regulatory inspections.
  • A postgraduate diploma in GMP is advantageous.
  • Preferably experienced in an aseptic compounding unit, though sterile manufacturing experience, including fill/finish and terminal sterilization, will also be considered.
  • A degree in microbiology or related continuing professional development (CPD) or experience is advantageous.

Skills and Abilities

  • In-depth knowledge of regulations, including MHRA requirements, GMP, and QA guidance.
  • Ability to motivate, develop, and lead a team.
  • Strong coaching and training skills for team and individual development.
  • Self-motivated, energetic, and positive work approach.
  • Excellent written and oral communication skills with the ability to influence others.
  • Strong planning, organizational, multitasking, project management, and change management skills.
  • Ability to critically analyze business situations, proactively plan, resolve problems, and seek continuous improvement.
  • Detail-oriented with a focus on quality.
  • Mature team management skills for effective collaboration within and outside the business.
  • Results-focused, action-oriented, and resilient under pressure.
  • Knowledgeable in the manufacture and clinical use of medicines.
  • Proficient in IT skills, including email and Excel.

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