Technical Operations Director
Our client, a medical device company in Cork is currently looking to recruit a Technical Operations Director for their site.
Responsibilities of the Technical Operations Director:
- Direct all activities of the Technical Services department. Ensure that all equipment and processes are qualified and validated according to cGMP and all relevant procedures. Ensure that all changes are approved through the formal change control process and to provide technical support to the QC and Manufacturing areas on site. Ensure regulatory compliance is maintained and site technology transfers are implemented in accordance with best practise.
- The Technical Services Director is responsible for ensuring the required competencies, talent management and development of people.
- With a solid line to the Site Lead and dotted line to a Regional GTO leader, the Technical Services (TS) Director will align with the GTO leader at the regional or global levels for maintenance of functional excellence and standard approaches.
- The Technical Operations Director will leverage the association with the Regional GTO Group that provides external partner support, to collaborate on providing technical support to external partners within the region as a secondary responsibility.
- Responsible for all aspects of technical process support including problem resolution, process improvements, technology transfers, process maintenance to Drug Substance , Pharmaceutical, Vaccine, Biologics manufacturing and packaging
- Participate and comply with the Mfg Division Quality Management System (QMS) requirements, including ownership, as relevant to you.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the Technical Services Department on projects, such as problem solving standardization, lean principles within the process.
Qualifications required for the Technical Operations Director:
- BSc, MS or PhD in Engineering, Pharmaceutics, Science or Equivalent and minimum of 10 years’ experience post BSc
- Minimum Green Belt (Desirable Black Belt qualification)
- Demonstrated evidence of Continuous Professional Development
- Desirable project management qualifications such as Project Management Professional
- Demonstrated application of culture and business change methodologies (CEM, Inclusion and BCCM) when realizing site and cross functional process improvement initiatives.
- Demonstrated Technical Expertise in one or more of Drug Substance, Pharm, Biologics, Vaccines, Sterile, Packaging with a demonstrated track record of applying scientific, technical knowledge and problem solving approaches to deliver business results
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, etc).
- At least 10 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in operations environment.
- > 5 years in a leadership role
- Knowledge of and experience in applying Six Sigma and Lean methodologies.
- Demonstrated leadership and change management skills with a continuous improvement focus.
- Project management experience leading projects
- Demonstrates Inclusion and Leadership behaviours, including integrity, resilience and flexibility.
- Demonstrated capability to lead a large, diverse team
- Demonstrated ability in holding team members responsible for results and being decisive about non-performers
- Demonstrated ability to realize improvement initiatives
- Demonstrated successes in a team environment such a project teams, Six Sigma team, etc.
- Demonstrated high level of problem solving and facilitation skills
- Advanced PC skills such as MS Office
- Stakeholder management of multi-decision makers, colleagues, peers and cross functional teams
For further information on this Technical Operations Director role in Cork please contact Anna McGowan on 0864667369 / email@example.com
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