Overview
Quality Vaccine IPT Lead to provide Quality leadership to an Integrated Process Team (IPT) to manufacture and supply quality pharmaceutical products with priorities of: Compliance, Supply, Strategy and Profit Plan. Primary focus is to ensure straight through product flow and that the team meets all product quality and compliance requirements to enable disposition for each batch. The IPT Quality lead provides technical expertise, support and advice to IPT on all Quality Assurance and cGMP compliance aspects. Liaises with QO CoE and supports IPT in continuous improvement activities and projects from a QA standpoint in the spirit of Lean Thinking and Lean Manufacturing. The IPT Quality lead supports Permanent Inspection Readiness and represents Quality Operations to the IPT. The leadership style is collaborative, coaching and facilitating the IPT to a high-performance organisation. This role requires substantial time within the IPT process, engaging with all IPT members to ensure the independent voice of Quality is understood and heard throughout the IPT. The IPT Quality Lead is accountable for Quality oversight within the IPT value stream and will manage a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The role acts as an active member of the cross-functional IPT Team, providing independent quality technical expertise and advice on all Quality Assurance and cGMP compliance aspects.
Primary Activities / responsibilities
* Ensure supply and straight through product flow and ensure the team meets all product quality and compliance requirements to enable disposition for each batch, through the implementation and oversight of the Quality Management System for the IPT
* Champion the highest Quality and compliance standards for the IPT
* Champion Permanent Inspection Readiness for the IPT
* Lead Quality Team providing ongoing coaching and support to all Quality Team members, including identification and development of key talent and skills within the team
* Drive the Quality Team's performance so that every individual understands their contribution and how it impacts the site
* Sound financial stewardship, management and control
Position Specification
Continuous Improvements
Responsible for ensuring that the culture of Continuous Improvement in the Quality Management Systems is based on a solid foundation of compliance and regulatory requirements by utilising the Six Sigma tools.
Coaching and Training
Develop an effective, focused and strong Quality IPT team by understanding their abilities and contributions, broadening their skill sets to be agile for future business requirements. Provide tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful. Coach the IPT Leadership team on the required Quality standards and ensure full understanding of cGMP requirements.
Key Behaviours
* Focus on Customers, Including Patients – Focus the organisation on delivering value for customers, including patients, by understanding and meeting their needs.
* Collaborate – Actively listen and seek to understand differing perspectives; work together to achieve common goals.
* Act with Candor and Courage – Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.
* Make Rapid, Disciplined Decisions – Make timely decisions at the right level with the right data, and support them once made.
* Drive Results – Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results.
* Demonstrate Ethics & Integrity – Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and comply with all laws, policies and regulations; identify and address ethical issues.
* Build Talent – Build diverse talent with capabilities to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.
Work Experience
* Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g., Quality, Science).
* At least ten years’ experience in the Pharmaceutical industry or similar operating environment with experience in a management / leadership role in a Quality function.
* Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation.
Demonstrated leadership and change management skills with a continuous improvement focus.
Qualifications
* Degree or 3rd level qualification (Science, Quality). Desirable Microbiology or biotechnology.
* Desirable QP qualification.
* Evidence of Continuous Professional Development.
* Preference for Lean Six Sigma Green Belt.
Skill Set
* Quality and Process background.
* Proven track record of providing independent Quality expertise to Manufacturing functions.
* Proven track record of delivering high performance through development and coaching of a team.
* Demonstrated ability in holding team members accountable for results and managing performance.
* Demonstrated ability to fully realize improvement initiatives.
* Demonstrated successes in a team environment (project teams, Six Sigma teams, PITs, etc.).
* Advanced PC skills such as Excel, Word, PowerPoint.
Requisition ID: R364166
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