ADL: L6 Senior Manager - Deviation Team Manufacturing Support

Overview: Reporting to the Director of Manufacturing Support, this position will manage the manufacturing deviations team for Amgen Dun Laoghaire (ADL).

The role has responsibility for leading a team of SMEs with the primary focus on manufacturing deviation lifecycle management. As part of the Manufacturing Senior Leadership team, the candidate will provide strong leadership and management support to the Vial and Syringe Manufacturing areas with responsibilities for overseeing the investigation and resolution of manufacturing deviations, ensuring compliance with regulatory standards, driving continuous improvement, lifecycle adherence, audit readiness and team development.

Key Responsibilities

• Build a culture of safety, quality and compliance throughout the deviation team, driving awareness and execution reliability through best practices, standard work and continuous improvement.  
• Build collaborative relationships with cross-functional teams to ensure the success of the site as a whole
• Foster a culture of diversity, inclusion and belonging within the manufacturing team and the ADL site.
• Leadership and Management: Lead and mentor a team of deviation investigators, providing guidance, support, and development opportunities.
• Deviation Management: Oversee the investigation and resolution of manufacturing deviations, ensuring timely and thorough root cause analysis, corrective and preventive actions, and documentation.
• Compliance: Ensure all deviation investigations comply with regulatory standards, company policies, and industry best practices.
• Continuous Improvement: Identify trends and areas for improvement in manufacturing processes, and implement initiatives to enhance efficiency, quality, and compliance.
• Stakeholder Collaboration: Work closely with cross-functional teams, including Quality Assurance, Production, Engineering, and Regulatory Affairs, to ensure effective communication and resolution of deviations.
• Reporting and Documentation: Maintain accurate and up-to-date records of all deviation investigations, and provide regular reports to senior management on the status and outcomes of investigations.
• Audit readiness and team co-ordination for regulatory inspections.

Qualifications and Experience

• Education: Bachelor’s degree in a relevant field such as Engineering, Manufacturing, Quality Assurance, or a related discipline. A Master's degree is preferred.
• Experience: Minimum of 6-8 years of experience in manufacturing support, quality assurance, or a related field within the pharmaceutical, biotechnology, or medical device industry. Previous experience in a leadership role is essential.
• Skills: Strong leadership and management skills, excellent problem-solving and analytical abilities, and effective communication and interpersonal skills.
• Knowledge: In-depth knowledge of regulatory requirements, quality management systems, and manufacturing processes. Familiarity with GMP, FDA, and other relevant standards and guidelines.

Personal Attributes

• Detail-oriented with a strong focus on quality and compliance.
• Ability to work under pressure and manage multiple priorities effectively.
• Proactive and self-motivated with a continuous improvement mindset.
• Flexible and adaptable, with the ability to lead a team through change.

Preferred Experience

• Knowledge of applicable regulatory guidelines
• Analytical problem-solving skills
• Clear communicator both vertically and horizontally through multiple channels
• Ability to motivate and enable cross-functional collaboration
• Comfort with complexity and ambiguity with an ability to see the big picture
• Ability to collect, digest and assemble information to enable decision-making
• Ability to partner with other departments
• Considerable organization skills
• Project management skills
• Strong communication skills, verbal and written
• Understanding of formal Risk Assessment tools
• Experience in coaching, mentoring and counselling
• Ability to deal with and manage change
• Ability to set goals and manage them to completion
• Team leadership skills:  Supervision, influencing, delegation, coaching and mentoring, conflict resolution across permanent and contract staff