Manufacturing Manager
This is a senior leadership role with overall responsibility for the inspection area in our manufacturing facility. The successful candidate will be responsible for leading a shift team to ensure safety and compliance standards are maintained while delivering flawless execution of the manufacturing schedule.
1. The key responsibilities include:
* Ensuring safety, quality and compliance in the inspection area
* 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
* Contributes to and assists with corporate, FDA, HPRA and other regulatory agencies during GMP audits and is responsible for corresponding follow up actions
* Ensures 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 SOPs and to GMP standards
2. 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 always available to meet the plan
* Communicating issues and promptly escalating issues that may jeopardize 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
* Recognizing 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 recognize 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
3. Communication and Escalation
* Strong communication skills both written and orally with the power to influence at different levels of the organization
* 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
4. People Management:
* Responsible for developing the best team by:
o Recruiting, interviewing and onboarding staff to meet headcount requirements in accordance with resource models
o Developing staff competencies through training, coaching and succession planning to ensure a pipeline of talent to progress through the organization
o Creating a culture of diversity, inclusion and belonging to ensure every team member feels valued at Amgen
o 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
Requirements:
* Typically, 5 – 10 years' experience in a GMP environment with at least 3 years 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