Senior Qc Analytics Manager

Your mission The main purpose of the Quality Control (QC) Manager is to manage a team of QC analytical scientist/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.
Job Description Key Responsibilities Ensure day-to-day management the QC analytical ensuring the laboratory is inspection ready and that any data generated is valid an in compliance with applicable internal and external cGMP requirements.
Overseeing the Quality Control department to support the quality control release and stability testing of gene therapy products and associated materials.
Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff.
Develop and manage the site testing schedule to ensure testing is complete by the required timelines.
Plan and assign work to the team to achieve the most efficient use of personnel and resources.
Responsible for running and maintaining the QC lab(s) to GMP compliance.
Manage the stability programme and ensure testing is complete within the required test windows.
Support any incoming material testing to ensure adequate supply of materials.
Ensure all quality events (Deviations, CAPA, OOS etc) investigated and closed in timely manner.
Responsible for reviewing all analytical data generated within the QC analytical team Responsible for organising and reviewing testing with 3 rd party collaborators.
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.
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.
Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
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.
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.
Support the Ireland site when necessary.
Key Job Competencies Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
Change Management - Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
Technical Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others with expert knowledge; accepts feedback from others; gives appropriate recognition to others.
Cost Consciousness - Works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources.
Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
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 and promoting data integrity.
Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
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 Background 7+ years working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site.
Experience of managing a team people within a cGMP QC analytical environment Degree in a relevant scientific discipline element (or equivalent) or relevant experience.
Understanding of GMP requirements e.g.
legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g.
of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10.
Good Collaboration, Communication and Conflict resolution skills.
Experience in audit inspections.
Good technical writing skills.
Wants to learn and have a natural curiosity to understand systems and processes.
Ability to work in a fast-paced environment essential.
Apply for this job About us MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases.
We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson's disease program.
Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas.
With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development.
Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies.
Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule.
We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA).
The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
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