Shire Senior Quality Systems Specialist in Dublin, Ireland
As our Senior Quality Systems Specialist you will be responsible for supporting the implementation and management of Quality Systems for Shire external Biologics products. This will include monitoring and supporting the improvement of the quality systems according to Shire, GMP & GDP standards.
The Quality Systems must provide consistency, efficiency, and effectiveness of for external Biologics. In this role you will also provide support to the external Biologics Quality team and/or the greater Shire organisation.
Your scope of work may include Drug Substance (DS) manufacturing, Drug Product (DP) manufacturing, Final Drug Product (FDP) packaging and labelling operations, laboratory operations and batch disposition. You will focus on external activities performed globally at contract manufacturing organisations (CMO) and contract test laboratories (CTL) in support of commercial biologic drug substance, drug product and finished drug product manufacturing.
Additionally you will be responsible for working internally with the following areas: Batch/Lot Disposition, QA Operations, Site Compliance, Supplier Relationship & Management (SRM), Technical Services and Operations Excellence in support of external Biologics Quality. You will partner closely with other Technical Operation groups especially Business Process Owners, Internal QA, Operations, QC, Validation, Compliance, Regulatory and Supply Chain.
You will accomplish in this role whilst demonstrating the Shire leadership behaviors, the ability to think critically, analyse data effectively and exploring creative ways of working more efficiently. To succeed you will have a strong work ethic and be self-motivated while demonstrating abilities to multi-task and collaborate globally.
QUALITY SYSTEMS CORE RESPONSIBILITIES
Executes strategy and deploys procedures and/or business processes to enhance and maintain the following aspects of Quality Systems:
Assist in deployment of Global Quality Standards within the function. Assess new or revised standards, conduct gap analysis to local procedures, and support alignment activities for deployment.
Responsible for providing input to APQRs as per the agreed schedule. This includes completion of APQR chapters to support creation of the product specific APQR report.
Assist in global quality defect reporting ie Biological Product Defect reports and Quality Defect Reports
Responsible for providing feedback on implementation of the Shire Quality Systems in external Quality Biologics to the Business process owners (BPOs). This role drives process improvements, as agreed with the BPOs, via execution leads.
Obtain and analySe customer feedback to assess for improvements to the quality systems.
Responsible for supporting the deployment and management of the risk management process in external Quality Biologics. Support establishment and training of risk champions as applicable.
Responsible for deployment and management of Quality Management Review (QMRe) for the external Bio OpU. This may involve data collection and facilitation of QMRe.
Responsible for managing and reporting quality metrics including but not limited to: department scorecard, TOLT metrics, BOLT metrics, and weekly metrics.
Support root cause analysis for quality system trends; recommend actions to address trends. Where appropriate drive improvements to correct or prevent negative trends. Focus on quality systems including deviations, CAPA, and change control.
Provide training support to the external Quality Biologics team; focuses training on various quality systems as required.
Proactively identifies and drives remediation of risks within sphere of influence.
Lead or support the use of visual management to drive improvement of quality systems
Lead or support various projects as needed to either maintain or improve quality systems.
Support efforts to systematically improve the quality systems using lean methodologies.
Complete weekly updates and reports to demonstrate status of various quality systems.
QUALITY ASSURANCE SUPPORT RESPONSIBILITIES
Provide Quality Ownership for non CMO/CTL deviations, CAPAs and Change Controls including determination of root cause and identification of appropriate CAPAs
Support Quality Ownership of CMO/CTL deviations, CAPAs and Change Controls when necessary.
Support and/or facilitates the processes for both Material Review Board (MRB) and Non-Conforming Material Reports (NCMRs) as applicable.
Responsible for archiving and maintaining archives of Quality records as per Shire standards and procedures
Participate in Tech Ops governance meetings, ensuring appropriate escalation of trigger events
Assist in rapid escalation and cross functional evaluation of quality alerts and incidents which occur across the external Biologics operations.
Support Shire internal audits and external health authority inspections as necessary.
Support execution of various quality systems as appropriate to provide flexibility and agility across the External Quality, Biologics team.
Education & Experience Requirements:
Minimum Bachelor’s degree in pharmacy, chemistry, biology or a related discipline.
5 years’ experience working in a Quality Assurance or Quality Systems role in the pharmaceutical industry.
Experience in the biotechnology and/or pharmaceutical industry, preferably both. A diverse experience between Quality and Manufacturing/Operations preferred.
Experience with Contract Manufacturing Operations (CMO).
Thorough understanding and experience with quality systems, cGMPs, GDPs.
Experience with API manufacturing, Aseptic/ Sterile Processing and Packaging and labelling.
Experience training and/or implementing root cause analysis and effective investigation practices
Experience in interacting with health authorities including involvement with agency inspections.
High level of professional competence. Preferably demonstrated by objective certification (.e.g. Certified Quality Auditor).
Must be flexible and comfortable with change.
Must be able to prioritise and multitask in an environment with changing priorities.
Must be willing and able to travel up to 5% of the time for training and/or collaboration.
Project Management / Operational Excellence experience with Lean, Six Sigma, or both desirable.
Experience working cross-functionally across multiple sites and/or time zones.
Some experience of Quality Control experience and/or experience working with Contract Test Labs also desirable.
Key Skills and Competencies:
Good verbal and written communication skills to establish rapport and develop relationships with key stakeholders.
Critical thinking/ evaluation of process problems
Ability to conduct data trending and evaluation to properly identify critical trends
Strong work ethic and ability to self-motivate while working independently
Ability to work in ambiguous situations.
Complexity and Problem Solving:
Adept and skilled at technical problem solving, having demonstrated and applied these learnings in a manufacturing environment.
Responsible for robust and timely execution of non CMO/CTL investigations, CAPAs and changes
Provides input to the Quality Leadership team regarding Quality goals and priorities.
Provides input to the Operating Unit team regarding overall OpU goals and priorities.
Monitors established goals and projects and takes action as needed to ensure timely delivery of goals
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.