QC Analytics Team Leader

QC Analytics Team Leader

Permanent employee, Full-time · Shannon

The purpose of the QC Analytics Team Lead is to manage a team of QC analyst’s/Senior QC analyst’s for the QC release testing and stability testing of gene therapy products and associated materials used for manufacturing to EU and US GMP requirements.

Responsibilities

• Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff
• Plan and assign work to the team to achieve the most efficient use of personnel and resources.
• Ensure all quality events (Deviations, CAPA, OOS etc.) investigated and closed in timely manner. 
• Responsible for reviewing analytical data generated within the QC analytical team 
• Ensure all direct reports or persons are fully trained for tasks they perform and maintain a high standard of record keeping and documentation so that information is clearly captured, disseminated and reported. 
• Support the development, qualification, validation and implementation of analytical methods within QC. Ensure all equipment is within calibration and operational to support the testing schedule
• Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
• Contribute to cross departmental activities and providing expert advice and technical input where needed.
• Assure the data integrity of all activities is maintained throughout the data lifecycle.
• Responsible for ensuring that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance’s, and is undertaken in accordance with applicable procedures (e.g., SOP’s, Protocols, etc.)
• Ensure area compliance with Quality, Safety and Environmental systems and procedures
• Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved
• Support with all reasonable senior managerial requests and ad-hoc tasks
• Support with regulatory documentation and act as key point of contact during inspections
• Assistance with the development and updating of SOPs and laboratory documentation
• Maintain QC facilities to meet GMP requirements, conduct necessary checks to support any health authority, customer/stakeholder site visits
• When required may be assigned testing of gene therapy products in accordance with product specifications to ensure all testing is completed within the required timelines in alignment with the production schedule. 
• Responsible for ensuring that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance’s, and is undertaken in accordance with applicable procedures (e.g., SOP’s, Protocols, etc.)
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.

Additional Activities

• Assist in the introduction of new analytical methodology for testing gene therapy products

Key Performance Indicators

• All testing performed meets QC KPI requirements
• Internal quality control audits
• Plan, manage and record training effectively

Key Job Competencies

• QC testing of products to GMP requirements.
• Maintenance of Laboratories to GMP standards.
• Analytical - Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data.
• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations.
• Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others.
• Cost Consciousness - works within approved budget; develops and implements cost saving measures.
• Motivation - achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence.
• Planning/Organising - prioritizes and plans work activities; uses time efficiently.
• Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
• Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

Job Responsibilities

• Compliance with GMP

Job Background

• Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics,).
• Demonstrate knowledge/experience of a GMP environment and quality control within a pharmaceutical or other regulated industry.
• Line management experience.
• Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred.

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