- Apr 24, 2023
On behalf of Horizon Therapeutics, we are currently seeking an Associate Director, Manufacturing Operations to join their Waterford manufacturing site on a permanent basis.
The role is responsible for delivering a flexible and challenging production schedule whilst adhering to the very highest safety, regulatory and quality compliance standards. The role is instrumental in the overall development of the operations team, with particular emphasis on the training, development, and retention of a highly versatile, engaged, and high-performing operations team.
Safety and Quality Compliance.
- Promote and play a lead role in developing and creating a positive Safety culture.
- Conduct weekly and monthly EHS inspections with the site Safety champion.
- Ensure that all work carried out complies with the required company, cGxP, regulatory, safety and environmental procedures, standards, and guidelines.
- Continuously ensure that all processes and procedures are up to date and in line with the latest revision of the relevant guidelines (E.g., Annex1).
- Drive a culture of being "Always Audit Ready" throughout the manufacturing operation.
- Key contributor to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
Leadership, Strategy & Goal Setting
- Provide the required leadership, drive, and energy to deliver on the company's strategic plans.
- Develop functional goals in line with the site and strategic goals.
- Generate capacity models for Equipment and Personnel and develop plans for both to ensure the function achieves its operational and strategic goals
Fill Finish Operations:
- Responsible for the manufacture of Horizons Clinical and Commercial products, including formulation, filling, and Inspection.
- Manage daily production schedules and resources to achieve high levels of performance and engagement, ensuring manufacturing expectations and targets are met or exceeded.
- Facilitate tier boards within the fill-finish area and report upwards within the tier process.
- Measure the Manufacturing team's performance against Key Performance Indicators and identifies appropriate corrective actions and countermeasure to offset negative trends.
Team and Development
- Ensure production area is adequately resourced within budget
- Ensure appropriate training and development for the operations team ensuring they have the required skills and confidence to execute right the first time.
- Effectively manage the Department including performance management, coaching, and mentoring to higher levels of capability.
- Drives Environmental performance of the manufacturing cleanrooms through strict cleaning regime and contamination control adherence.
- Supports MSAT, Validation, Sterility Assurance, Calibration and Maintenance activities to ensure these processes are facilitated by manufacturing for completion on time and right first time.
- Lead and support technical/other investigations through structured root cause analysis.
- Plays a key leadership role in the identification of operational excellence processes that will be required to prepare for increasing volumes.
- Prepare and oversee the department budget including timelines, resource demands and allocations.
Qualifications and Skills Required:
- Qualified to a minimum degree level in the science-related discipline. (e.g., biotechnology, chemistry, bio/chemical engineering, mechanical engineering etc.).
- 15+ years of experience in pharmaceutical industries, with minimum 7 years of managerial experience within a fill-finish environment.
- Proven experience and demonstrated ability to work in cross-functional groups and liaise with people in the organisation to obtain results
- Experience in presenting to regulatory authorities as an SME
- Strong attention to detail and excellent organizational skills are required.
- Analytical Decision Making and Problem-Solving Skills.
- Ability to manage multiple conflicting demands and prioritise accordingly.
- Operate comfortably in a fast-paced changing environment and with a sense of urgency.
- Demonstrated project and/or program management skills required.
- SAP experience an advantage.
- Performance Management and People Development.
- Natural team player.
- Proficient in Microsoft Office.
- Professional, proactive demeanour.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.