Shire Quality Systems Lead in Dunboyne, Ireland
As our Quality System Lead you will lead the Quality Assurance (QA) Systems function at our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases.
The overall responsibility for this role will be to manage, plan and direct the Quality Systems and compliance team, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Site leadership organisation to help create value for our patients.
As a green field start-up facility, our Quality System Lead 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.
You will ensure site quality systems comply with changing requirements and trends in worldwide GMPs.
Management of the site GMP quality systems including the following:
Vendor and Service Supplier Management
Annual Product Quality Review (APQR)
Support the hiring, development and coaching of key members of the Quality Assurance Systems team to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
Management of site auditing activities, including regular self-inspections, annual internal auditing and auditing of GxP vendors and service suppliers (as applicable).
Managing the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
Responsible for inspection readiness activities including reporting and escalating inspection risks along with development and execution of actions focused on risk mitigation. This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required.
Responsible for the Site Master File including working with responsible groups to complete updates in accordance with procedural requirements.
Responsible to manage and/or support APQR activities in partnership with Quality Systems and Center Function.
Responsible for inspection responses within defined regulatory timelines and generation of the associated CAPA plans.
Preparation, review and approval of GMP documentation, including SOPs, policies, analytical documentation, manufacturing documentation and material specifications.
Incorporation of global standards and procedures into site Quality Systems.
Preparation of Key Performance Indicators to align with company and global quality objectives.
Management of the site Quality Council Process and liaison with global Quality with regard to this process.
Management of the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
Implementing efficiency improvements in Quality Dept. on a continuous basis and participating in site projects and initiatives.
Motivation, training, discipline and appraisal of Quality Systems and Compliance personnel.
Build safety as a key value within the Quality Assurance teams and maintain sustainable EHS programmes that are engrained within the department.
Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable,
Maintaining daily staffing requirements to meet business needs
Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually improve processes.
Responsible to act as an interface (in conjunction with the Head of Quality (QMR)) between Dunboyne Site Quality and the supporting Central Quality support functions (ex. Central Product Testing, Clinical QA, Center QA Validation, and others) to ensure site support needs are met.
Education & Experience Requirements:
A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering).
At least 10 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 ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.
Experience in leading regulatory inspections, performing internal audits and participating in external audits.
Exceptional analytical, problem solving & root-cause analysis skills.
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
Strong operations support background ensuring value added and effective quality oversight.
Key Skills and Competencies:
Ability to translate the vision and goals of the company and site to the Quality Assurance 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 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.
Promoting a culture where diversity and inclusion is part of the DNA.
Complexity and Problem Solving:
Identifying and communicating risks in area of responsibility and across the site.
Creating strategies and plans to manage risk within the Quality Assurance function.
Notice to Employment / Recruitment Agents:
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.