Shire Quality Assurance (QA) Disposition Lead in Dunboyne, Ireland
To provide strategic Quality Assurance (QA) oversight and leadership at the Piercetown, Co. Meath Biologics start-up facility to meet functional and site goals and objectives.
As a green field start-up facility, the individual will be responsible for assisting in identifying and implementing industry QA best practices including but not limited to internal processes that support manufacturing, Quality Management Systems (QMS), materials management, validation and Quality Control Laboratory readiness.
Support the hiring, development, leading and coaching of key memebers of the Quality Assurance team to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
Build safety as a key value within the Quality Assurance teams and maintain sustainable EHS programmes that are engrained within the department.
Ensures Quality Assurance - owned business systems are established and engage with the business systems owner to continually improve these processes.
Responsible for timely updates of site achievements and challenges. A collaborative approach, working cross functionally on resolving obstacles to maintain a highly effective and productive functional group.
Responsible for ensuring compliance with legal, EHS and all Shire policies and procedures which are applicable to the site.
Be an ambassador for the Shire leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
Role model the behaviours that creates a culture of respect and dignity in line with the Shire Guide for ethical conduct.
Ensure the independence of the QP team in decisions on Quality related matters.
Continuous improvement of the quality systems - Identifying and building in efficiencies as necessary from a systematic and compliance perspective.
Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to (e.g. CMO's / contract labs etc).
Ensure the Quality Leadership team (QLT) is appraised on all Quality related issues.
Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.
Excellent communication and negotiation skills promoting openness, dialogue and collaboration.
Results orientated with a strong ability to effectively troubleshoot and problem solve issues.
Act as a change agent to promote a culture of continuous improvement.
Drives leadership within the Quality Assurance department in meeting targeted site and Tech Ops quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.
Sustained performance through lean leadership, robust learning and development planning, organisation talent reviews and communication planning.
BuiIds partnerships within the Quality leadership team (QLT) to create and sustain a culture that demonstrates excellence in quality and continuous improvement.
Creates an environment of ‘ right first time’ in everything that we do through a focus on principles of lean, including simplification, standard work, visual management and a learning organisation.
Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function.
Once the Piercetown facility is operational, the successful candidate will be responsible for coordinating all QA duties relating to QP batch release in compliance with Regulatory requirements and GMP guidelines.
Pro-actively participate in the Quality Management process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required. Coordinate and provide QP support to QA colleagues with product quality / license impact assessment for deviations.
Responsible to act as an interface (in conjunction with the Head of Quality (QMR)) between Piercetown Site Quality and the supporting Central Quality support functions (ex. Central Product Testing, Clinical QA, Centre QA Validation, and others) to ensure site support needs are met.
A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering).
QP Eligibile (as required under the EU Directive 2001/83/EC) with previous experience in Drug Substance/Drug product Biologics batch disposition.
At least 12 years experience in the biotechnology and/or pharmaceutical industry, (preferably both).
A proven people leader capable of developing people and teams with at least 8 years of management experience.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
Demonstrated collaboration, negotiation & conflict resolution skills.
Excellent communication skills (written and oral).
Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
Demonstrated understanding of continuous quality / process improvement tools (As defined by the local site, e.g. DMIAC, Lean QA, 5S etc).
Experience in leading regulatory inspections, performing internal audits and participating in external audits.
Exceptional analytical, problem solving & root-cause analysis skills.
Ability to multi-task and handle tasks with competing priorities effectively.
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
Experience with working in a multinational organisation.
Strong operations support background ensuring value added and effective quality oversight.
Key Skills, Abilities, and Competencies
Ability to translate the vision and goals of the company and site to the Quality Assurance disposition team.
Enterprise mindset to ensure the right priorisation for the site.
Strong project management skills to support project delivery and operational readiness.
Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
A proven ability to lead a Quality Assurance disposition function (Biologics).
Excellent influencing/collaboration skills and teamwork mindset.
Excellent trouble shooting and problem solving skills as well as an ability to coach and mentor teams through complex problems.
Ability to challenge the status quo with a continuous improvement mindset.
Change agent who will support the organisation with good change management tools and techniques.
Strong talent developer with a focus on creating a continuous learning organisation through active coaching.
Effective communicator with a proven ability to grow talent and future leaders.
Promoting a culture where diversity and inclusion is part of the DNA.
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.