Shire Manager Quality Control (BioChemistry) in Piercetown, Ireland
This role will serve as the lead for all Quality Control Biochemical testing of in-process, stability, drug substance and final drug products 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 Control Biochemistry laboratory to ensure compliant testing and provide the highest quality Biochemical support for manufacturing, while ensuring compliance with cGMP and safety regulations. This is a critical role within the Quality leadership organisation to help create value for our patients.
Responsible for the Quality Control Biochemical related testing (in-process, stability, drug substance and final drug products) at the Shire Biologics start-up facility in Dunboyne, Co. Meath.
Hire, develop, lead and coach a team of Quality Control Chemists and drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
Responsible for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviours, performance and budget management.
Build safety as a value within the Quality Control team and maintain sustainable EHS programmes that are engrained within the department.
Responsible for generating Quality Control related documents which include Standard Operating Procedures (SOPs), Protocols, Technical Reports and Deviation Reports.
Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
Co-ordinate and manage laboratory investigations and approve any retesting required. Ensure that these investigations are completed correctly and closed out in a timely manner
Maintaining all laboratories in an inspection-ready, GMP-compliant state is critical to this role.
Involvement in various departmental and cross-functional teams and initiatives including inspection and regulatory support.
Ensures Quality Control-owned business systems are established and engage with the business systems owner to continually improve processes.
Lead the Quality Control Biochemistry laboratory in meeting targeted site and Tech Ops quality objectives, ensuring department objectives are aligned, translated to all and visually managed to drive delivery.
Create an environment of right first time in everything that we do through a focus on principles of lean, including simplifcation, standard work, visual management and a learning organisation.
Responsible for individual goal setting, ongoing performance reviews and development planning for direct reports and function.
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.
Education and Experience Requirements
Degree/post graduate qualification in a technical discipline such as biochemistry, chemistry, and engineering is desired.
At least 12 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both).
Proven people manager and leader capable of developing people and teams with at least 5 years of management experience.
Track record of effective Quality Control leadership for internal production facilities with experience driving out inefficiencies and improving laboratory turnaround times.
A background in Biochemical methods (SDS-Page, Glyco analytic, PCR, capillary electrophoresis and compendial assays). Knowledge of Biochemical Method Development, Biochemical Method Validation and Statistical Quality Control.
Experience leading, training and/or implementing root cause analysis and effective investigation practices.
Experience with working in a multinational organization.
Key Skills, Abilities, and Competencies
Ability to translate the vision and goals of the company and site to the Quality Control Biochemistry team.
Enterprise mindset to ensure the right prioritization 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 Control Biologics function.
Excellent influencing/collaboration skills and teamwork mind-set.
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 mind-set.
Proven ability in using a wide variety of lean tools and building capability within teams.
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.
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 Control operation.
Internal and External Contacts
For quality and compliance, collaborates with Quality Control Lead but accountable for creating a ‘ right first time’ culture in the Quality Control laboratories to support quality excellence.
For safety, the individual is accountable to drive a culture of ‘ everyone owns safety ’ with input from the EHS lead.
For delivery of the people strategy including recruitment, learning and development and organizational talent reviews, collaborates with business excellence and HR but is accountable to develop a high performing organization in the Quality Control Laboratories.
For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Shire and through external forums to drive business excellence in Quality Control.
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.