Lonza
AD QA Ops
Lonza, Portsmouth, New Hampshire, United States, 00215
Responsible for GMP activities in the customer-dedicated area. S/he is a key member of the Asset Leadership Team and acts as a Business Partner to the Asset Head in implementing strategic initiatives. Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance. Additionally, responsible for working and driving alignment with leaders of other assets onsite. The QA Associate Director-Operations ensures that manufacturing related GMP systems and controls meet Global Quality standards and applicable regulatory requirements. In addition, this role liaises with the customer on a regular basis and participates directly in Joint Quality Steering Committees to ensure that QA and compliance activities meet their expectations. Depending on the Asset, the incumbent typically has several direct reports (QA Managers, QA Supervisors, Compliance Specialists and/or QA Project Managers)and is responsible for overseeing the change control, deviation and CAPA lifecycle, GMP compliance, on the floor operational support, batch record review and lot release, review and approval of technical documentation as well as oversight of all validation activities in support of manufacturing operations within the asset. This position supports the overflow of tasks as needed, assigns resources and priorities, ensures adequate training, coaches and develops staff, and evaluates performance. This role is a member of the Senior Quality organization and participates in decisions and escalations at the site.
Key Responsibilities:
Leads the overall quality strategy within the asset
.• Provides general direction and support and acts as a point of escalation for QA staff and customers
.• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.
• Attends Site Quality Council and Lot Disposition meetings
.• Managesand tracks Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management. Performs Lot Release/Disposition activities
.• Identifies and implements improvements to quality processes.
• Provides general direction for department. Develops team goals, monitors progress and ensures continuous improvement.
Qualifications:
Bachelor's Degree in a Science related field
5+ y ears of experience
Key Responsibilities:
Leads the overall quality strategy within the asset
.• Provides general direction and support and acts as a point of escalation for QA staff and customers
.• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.
• Attends Site Quality Council and Lot Disposition meetings
.• Managesand tracks Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management. Performs Lot Release/Disposition activities
.• Identifies and implements improvements to quality processes.
• Provides general direction for department. Develops team goals, monitors progress and ensures continuous improvement.
Qualifications:
Bachelor's Degree in a Science related field
5+ y ears of experience