Overview: Head of Quality Services and Improvement (QSI) job vacancy in Dublin recruiting now
Employer: Takeda Pharmaceuticals International GmbH
Location: Dublin, Ireland
Employment Type: Permanent
We’re looking for a candidate to fill this position in an exciting company.
How you will contribute:
Incorporates integrity, fairness, honesty and perseverance into all work activities.
The responsibilities of the Quality Services and Improvement Lead include:
- Defining and monitoring strategic objectives for the Quality function in line with site and Global Quality objectives.
- Develops, executes and reports performance metrics for the external biologics site, in alignment with Takeda’s operating model, that integrates Continuous Improvement and supports Takeda’s oversight of compliance and business performance.
- Leading change and continuous improvement for the function and site.
- Managing and promoting the site’s Agile program in alignment with Takeda’s Agile programs.
- Defining and leading innovation projects within Quality and participating in site innovation projects. Digital projects will be a key focus.
- Leading the site’s Quality Culture program and embedding a real culture of quality throughout the site.
- Defining and continuous monitoring of the Quality budget (Operational).
- Resource planning and monitoring of resource requirements within Quality.
- Implementing, monitoring effective Key Performance Indicators within Quality that are aligned to quality objectives and improving process performance.
- Effectively promoting and communicating Quality Improvement activities to the External Biologics site and the Takeda Global organization.
- Mentoring quality personnel is part of the role.
- Leading challenging investigations through established principles of Lean Six sigma (e.g. DMAIC).
- Assuming responsibilities in any work area of the External Biologics Quality Department as required by business needs.
In partnership with other members of the organization:
- Providing support to External Operations area in terms of routine operations.
What you bring to Takeda:
- Primary Degree in a scientific discipline.
- Green Belt training is desirable and Black belt training is an advantage.
Other Essential Requirements:
- Minimum of 8 years’ experience in the pharmaceutical industry
- Minimum of 4 years’ experience in a Continuous Improvement / Agile role with demonstrated success in this area
- Experience in parenteral biological manufacturing particularly in the requirements for manufacture of sterile medicinal products (EU GMP Volume 4, Annex 1) and or manufacture of biological active substances and products (EU GMP Volume 4, Annex 2).
- Experience with collaborative working with Contract Manufacturing Organisations (CMO).
- Technical report writing and reviewing.
- Experience with product supply chain architecture.
Key Skills, Abilities and Competencies
- Strong Leadership and Interpersonal skills
- Excellent knowledge of cGMP
- Lean / 6 sigma / AGILE experience
- High level of initiative
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
- Ability to creatively identify innovative solutions.
- Excellent mentoring skills and the ability to bring a team together.
- Proven ability to create a vision and motivate others to achieve that vision.
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team,
- Ability to create an enabling culture and corresponding high performing teams. Proven ability to manage and deliver business results and to champion change
- Business acumen.
- Fluent in English.
- Proficient in technical report writing and assessment.
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