Quality Lead Vaccine IPT

Job Description

An exciting opportunity to join the Brinny team as Quality Vaccine IPT Lead.

This role will provide Quality leadership to an Integrated Process Team (IPT) to manufacture and supply quality pharmaceutical products with Priorities of: Compliance Supply Strategy and Profit focus of position is to ensure straight through product flow and to ensure the team meets all product quality and compliance requirements to enable disposition for each batch. The IPT Quality lead is therefore responsible for providing technical expertise support and advice to IPT on all Quality Assurance and cGMP compliance aspects. Liaising with QO CoE supports the IPT in all continuous improvement activities and projects from QA standpoint in spirit of Lean Thinking and Lean Manufacturing. The IPT Quality lead is responsible for supporting Permanent Inspection Readiness and represents Quality Operations to the IPT. The leadership style is one of collaboration coaching and facilitating the IPT team to a high-performance organisation. This will require a substantial amount of his/her time within the IPT process engaging and communicating with all IPT members to ensure that the independent voice of Quality is understood and heard throughout the IPT. The IPT Quality Lead is accountable for the Quality oversight within the IPT value stream. This requires the management of a robust Quality Management System to support a flexible collaborate multi-skilled teamwork environment. They will be active member within the cross functional IPT Team providing independent quality technical expertise support and advice to IPT on all Quality Assurance and cGMP compliance aspects.

Primary activities/responsibilities:

• Ensure supply to ensure straight through product flow and to 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 the identification and development of key talent and skills within the team.
• Drive the Quality Teams performance so that every individual understands their individual 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 adhering to regulatory requirements by utilising the Six Sigma tools.

Coaching and Training

Develop an effective focused and strong Quality IPT team by understanding: their abilities unique contribution and broadening their skill set to be agile and prepared for any future business requirements. Provide your team with the 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 they have full understanding of cGMP requirements.

Key Behaviours:

Focus on Customers Including Patients

Focus the entire 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 the common goals of the company.

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 hold others to the same standards; comply with all laws policies and regulations; identify and address ethical issues without hesitation.

Build Talent: Build diverse talent with the capabilities necessary 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 etc.).
• At least ten years experience in the Pharmaceutical industry or a similar operating environment which includes 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 such as project teams Six Sigma team PITs etc.
• Advanced PC skills such as Excel Word PowerPoint.

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Current Contingent Workers apply HERE

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Employee Status: