QA Operations Senior Specialist
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QA Operations Senior SpecialistApply Now
This role will provide Quality Assurance (QA) oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the Takeda single use multi-product biotech facility in Dunboyne, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Takeda.
The overall responsibility for this role will be to support the Operations team, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality leadership organisation to help create value for our patients.
- Support the development and coaching of key members of the Quality Assurance Operations team to drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
- Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial operations at the facility.
- Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.
- Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.
- Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.
- Responsible for ensuring execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
- Reviews and approves batch records, discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations.
- Liaises with internal partners (e.g. Manufacturing Operations, Process development Technical services (PD-TS), Engineering functions etc) in support of daily operations.
- Ensures clear communication on issues and timely escalation as applicable.
- Drives opportunities for continuous improvement.
- Provide direct audit support, and participate in response team for audits and inspections by Health Authorities.
- Coordinate with peer internal Quality Groups to ensure on-time disposition of commercial drug substance material.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
- Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable,
- Leading and/or representing Quality on multidisciplinary teams.
- Promote and exhibit Takeda Values.
- Executing company policies.
- Ensuring self inspections are performed.
- Ensures new/revised quality system requirements are deployed to the Site.
- Ensures execution leads for Quality-owned business processes are established who subsequently work with the business process owner to continually improve processes.
Education and Experience Requirements
- A minimum of a Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering).
- At least 7 years experience in the biotechnology and/or pharmaceutical industry, (preferably both) within a Quality Operations role.
- 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).
- Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.
- Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
- Experience in 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
- 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.
- 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.
- 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.
Internal and External Contacts
- For product quality, collaborates with Process Development Technical Services (PDTS) and Manufacturing Operations but is accountable for providing all information to support the QMR decision.
- For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality Assurance group 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 Human Resources but is accountable to develop a high performing organization in the Quality Assurance group.
- For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in Takeda and through external forums to drive business excellence in Quality Assurance.
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, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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.
Job ID SR0037076