Manufacturing Manager (Inspection)

Career Category

Job Description

Manufacturing Manager ‐ Inspection - Amgen Dun Laoghaire ‐ Dublin

Overview:

The Manufacturing Manager ‐ Inspection (Inspection FLM) will report to the Sr. Manager for Inspection and Packaging and will be responsible for leading a shift team 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 shift role (4 cycle).

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. Can 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.

Job Scope:

Production Management

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.

• 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 SOP’s and to GMP standards

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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 always available 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.

• 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.

Accountable for 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.

People Management:

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 organization

• 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 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.