Integrated Process Team (IPT) Director
The IPT Leader is the business unit manager for the Integrated Process Team (IPT),and represents the IPT reporting into the Site Leadership Team. As a member of the site extended Leadership Team, you play a key role in the development of policy and co-ordination of overall site operations. You are accountable for achieving the process outcomes for the IPT and provide tactical and strategic direction to the cross-functional managing team of the IPT, promoting the behaviors and principles that drive continuous improvement.
You will support the development and maintenance of a positive relationship with the local community. Ensure that objectives are achieved at the lowest cost consistent with company, Regulatory Agency and State and Local code requirements for quality, equal employment opportunity, employee and environmental safety and health thereby ensuring compliance, safety and reliable supply to our customers.
- Leadership activities including selection, development, coaching and day to day management.
- Lead Integrated Process Team (IPT) daily walkthrough. Determine appropriate management of events and facilitate post mortem of event management process and solution.
- Provide purchasing approval (within Grant of Authority) for IPT.
- Develop strategic initiatives related to equipment and human resources in support of long range operating plans.
- Approve the instructions relating to production operations and to ensure their strict implementation.
- Check the maintenance of the department, premises and equipment.
- Ensure that the appropriate validations are done.
- Set short, medium and long term strategy and direction for the IPT function, ensuring Company objectives are achieved effectively.
- Responsible for development and management of the operating budget as defined with the profit plan.
- Assists in the development of the capital plan and management of capital projects for the IPT.
- Accountable for compliance with cGMP and Safety, Environmental, Employment, and Industrial Health
regulations for processes associated with the IPT.
- Supports atypical investigations, audits and responses to governmental agency requests.
- Accountable for informing other COE management and the Process Owner (Plant Manager) about situations and/or trends that are affecting IPT performance (atypical, accidents, events, audit findings, regulatory issues, among others) and requests support as needed.
- As a result the IPT Leader is responsible for ensuring all production responsibilities outlined in the relevant audit criteria, such as Chapter 2, are fulfilled by the relevant person(s) on site
- Accountable for achieving our Production System targets and business results for the IPT. Reports monthly metrics and any action plans to address gaps for the IPT to the Site Leadership team.
- Accountable for implementation of corrective actions identified in Continuous Improvement Audits. Identifies, prioritizes, and champions capital projects and improvement projects to improve process efficiency, cycle time, and yield, reduce process variability, and eliminate waste.
- The IPT Leader and Director of Quality Operations generally have some shared, or jointly exercised, responsibilities relating to quality. These include;
— the authorisation of written procedures and other documents, including amendments;
— the monitoring and control of the manufacturing environment;
— plant hygiene;
— process validation;
— the approval and monitoring of suppliers of materials;
— the approval and monitoring of contract manufacturers;
— the designation and monitoring of storage conditions for materials and products;
— the retention of records;
— the monitoring of compliance with the requirements of Good Manufacturing Practice; 3 Article 53 of Directive 2001/82/EC
— the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
- In conjunction with the Site Leadership Team members, responsible for the overall leadership management of the Carlow IPT function; responsible for contributing to any site management initiatives and ensuring that the expertise and resources of the IPT organization are available to support any agreed initiatives.
- Drive compliance to our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
- Drive effective writing/revising/ rolling out of accurate operational procedures, training documents and procedures for various IPT systems; ensure all work is subsequently carried out in line with same.
- To ensure that the production records are evaluated and signed by an authorised person before they are sent to the Quality Control Department.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
- Bachelors Degree or higher preferred; ideally in a related Business, Science, Engineering or other Technical discipline
- Six Sigma qualification preferred
- Significant experience in a comparable role; would typically have experience leading a functional area and contributing to the business at a directional, strategic level; ideally in a manufacturing, preferably GMP setting.
Core Competencies (Technical):
- Sterile filling processes and equipment
- Knowledge of regulatory/code requirements to Irish, European and International Codes,
- Standards and Practices
- Report, standards, policy writing skills required
- Understanding of business and operations management models and their application
- Recruitment and selection
- Proficiency in Microsoft Office and job related computer applications required
- Lean Six Sigma Methodology experience desired
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports
- Progressive people management skills
- Risk management skills
- Business acumen
- Strategy planning and development
- Ability to effectively manage complex projects across multiple disciplines
- Proven financial management skills
- Strong influencing skills
- Negotiation skills
- Strong change management skills
- Effective conflict resolution skills
- Demonstrable analytical and systematic problem solving skills
- Vendor liaison
- Goal/results orientated
- Focus on Customers and Patients
- Act with Candor and Courage