The GXP Process Excellence team is responsible for the implementation of integrated frameworks, systems, information paths and competencies across the External Operations product lifecycle.
Headquartered in Dublin, our client is a global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis.
The hiring manager for this role has over 25 years' experience across various Process Engineering, Validation and External Operations roles during where she has lead and facilitated global cross-functional project teams.
The successful candidate will be responsible for the implementation of integrated frameworks, systems, information paths and competencies across the External Operations product lifecycle. The role will provide leadership and oversight to cross-functional groups to enhance process understanding and measurement capability with specific responsibility in the areas of Statistical Process Excellence and risk-based approaches.
- Provide technical leadership in developing, implementing and maintaining External Operations management systems across the product lifecycle.
- Create and maintain a knowledge base of key process and performance information on external manufacturing capabilities.
- Challenge current methods and practices offering innovative ideas and solutions to enhance performance across the product lifecycle.
- Execute priorities in line with business strategy, providing clarification and work with key stakeholders to ensure objectives are achieved. Builds partnerships with Internal and External stakeholders that benefit the overall performance of the organisation.
- Apply statistics and risk-based approaches to process understanding and continuous improvement.
- Implementation of statistical methods and procedures for the measurement and evaluation of process control and process capability.
- Implement data collection plans, statistical methods and procedures for measuring and evaluating process control and process capability.
- Create procedures to guide statistically based conclusions on level of process control and process capability; enable recognition of where further evaluation is required and to what level based on statistical methods.
- Contribute to the External Operations vision to ensure supply chain robustness within the production network through the application of business and process understanding methodologies which are underpinned with a continuous improvement and process control mindset.
- Facilitate multi-department teams in executing risk assessments and development of data collection plans to monitor the manufacture of drug products by utilising statistical methods and procedures to measure and evaluate process control and process capability.
- Direct interaction and presentation of data to demonstrate to regulatory authorities the adequacy of our implemented processes, systems and controls.
- Flexibility in leading or working as part of a team as the need arises, preparation of documentation relevant to the role and demonstrate initiative in idea generation and development of systems to support the role.
- Comply with all aspects of cGMP, Safety and Environmental legislation and Company policy where impacts on the role.
- Maintain and enhance job knowledge by participating in educational opportunities; use of professional publications; alignment with professional organizations/societies; maintaining personal networks; monitoring financial guidelines and requirements, etc.
- Enhance team, department and organization reputation by accepting ownership for accomplishing new and different requests.
- The role may require ~20% of international travel.
External Operations leadership and Technical Operations; Outside vendors (including CMOs) and service providers
- Bachelor's Degree in Science, Engineering or similar Technical discipline
- Minimum of 10 years relevant experience in a pharmaceutical drug product manufacture or development environment.
- Professional or chartered status with a relevant professional body is advantageous.
Skills, Knowledge and Behaviours
- Experience of Process Excellence and demonstrated ability to develop key organizational systems and/or frameworks
- A high level of proficiency in the application of statistics to interpreting data; predictive and modeling experience is desirable.
- Experience of risk management and risk assessment; demonstrate an understanding of how to effectively lead a risk assessment activity, appropriate tool selection and the risk management lifecycle.
- Demonstrates an effective, flexible and collaborative communication style, including excellent verbal, written communications, presentations skills and influencing skills.
- Facilitation and process mapping experience is advantageous.
- Subject Matter Expert level of process, equipment and control across the pharmaceutical drug product lifecycle for a range of in process and finished product technologies, including design and control of these processes.
- Knowledge of global regulatory requirements and industry best practice concerning cGMP manufacturing, validation, quality systems, equipment innovations, upgrades and instrumentation to ensure manufacturing best practice.
- Demonstrate an expert knowledge of scientific and engineering principles as well as skills in change and program management.
- Oral Solid Dosage, parenteral and biologics technologies knowledge
- Teamwork/Leadership approach is collaborative to achieve acceptance and adoption of GXP Process Excellence initiatives.
- Technical expertise and desire to keep up with emerging advances and trends
- Decision making based on data and knowledge to resolve issues, seeks input from others, and uses consensus when possible
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.