**Inspection Front Line Manager (FLM) Amgen Dun Laoghaire – Dublin**
The Inspection Front Line Manager (FLM)– will report to the Sr. Manager for Inspection and Packaging and will be responsible for leading a shift of MPT’s, Associates and Sr Associates to ensure safety and compliance standards are maintained while delivering flawless execution of the manufacturing schedule. The successful candidate will have at least five to ten years of experience within the pharmaceutical or biotech industry and will have demonstrated competency in a manufacturing people management role. Please note this is a (FTE) role on a 24/7 shift pattern.
**The ideal candidate will have:**
+ Experience working in an inspection and/or packaging leadership role and have a working knowledge of automated visual inspection equipment from vendors such as EISAI, Brevetti, Seidenader and WILCO.
+ Have the ability to influence and lead cross functional teams to deliver both tactical and strategic objectives to ensure patient supply today and into the future.
+ Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates.
+ A passion for embracing a culture of diversity, inclusion and belonging within our workforce to ensure Amgen remains a best place for talent.
+ **Ensuring Safety, Quality and Compliance**
+ Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported and investigated in a timely manner. Promotes a positive safety culture within inspection.
+ Works in a collaborative manner with other functions to ensure robust deviation investigations and assumes ownership of subsequent CAPAs to prevent reoccurrence. Acts as a point of contact and functional area owner (FAO) for major deviations related to the inspection area and is responsible for ensuring deadline milestones are delivered on schedule.
+ Contribute to and assist with Corporate, FDA, HPRA and other regulatory agencies during GMP audits and is responsible for corresponding follow up actions.
+ Ensure the inspection area adheres to all relevant regulatory guidance documents.
+ Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP’s and to GMP standards
+ **Accountable for Delivering Results by:**
+ Participate in the goal setting process for the department and manage complex goals aimed at creating competitive advantage.
+ Supporting the creation of short, medium- and long-term schedules and being accountable for the on time in full execution against the plan.
+ Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan.
+ Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables.
+ Using project management principles to lead complex cross functional initiatives on schedule and within budget.
+ Supporting engineering, Process development and maintenance to improve the reliability of automated equipment within inspection and support the introduction of new inspection equipment during FAT, SAT and PQ qualification.
+ Recognising positive performance and sharing best practices with other departments and sites within the network.
+ Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions.
+ Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations.
+ Leading and sponsoring lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement.
+ **Accountable for Communication and Escalation**
+ Strong communication skills both written and orally with the power to influence at different levels of the organisation.
+ Providing inspection performance updates at various forums to audiences including senior leadership.
+ Escalating any issues which cannot be resolved locally in accordance with Amgen’s escalation policy.
+ **Responsible for developing the best team by:**
+ Recruiting, interviewing and onboarding staff to meet headcount requirements in accordance with resource models.
+ Developing staff competencies through training, coaching and succession planning to ensure a pipeline of talent to progress through the organisation
+ Creating a culture of diversity, inclusion and belonging to ensure every team member feels valued at Amgen.
+ Managing direct reports using MAP performance management systems, to ensure they meet the required performance standards, addressing issues with individuals where required to create a high performing team.
+ Be responsible for effective management of all direct reports including people management in line with the company’s disciplinary policy and standards, including active management of absenteeism, tardiness, lateness and holidays.
+ **Basic Qualifications & Relevant Experience preferred:**
+ Typically, 5 – 10 years’ experience in a GMP environment with at least 3 of which are in a people leadership position.
+ Bachelor’s degree in relevant science or engineering related discipline.
+ Working knowledge of inspection processes and equipment.
+ Knowledge of GMP regulation requirements mainly FDA and HPRA specifically related to the inspection of parenteral drug product.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.