Lonza
Associate Director, Quality Assurance Operations - LSA
Lonza, Portsmouth, New Hampshire, United States, 00215
Overview
Associate Director, Quality Assurance Operations - LSA – United States, Portsmouth (New Hampshire). Lonza offers the opportunity to lead central initiatives to boost quality standards and ensure cGMP compliance. Key Responsibilities
Own the overall quality strategy across Manufacturing Operations. Provide general direction and support, acting as a point of escalation for Quality Assurance staff and customers. Ensure objectives are met and align with customer Quality Agreements, Lonza SOPs, and regulatory requirements. Partner with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to resolve high-risk issues with Change Controls, Deviations, CAPA, and Investigations. Attend and/or co-chair Change Control Committee, Deviations Review Board, and CAPA Board meetings. Support customer audits and regulatory inspections. Manage and supervise Key Performance Indicator Quality Metrics, including monthly/quarterly deviation trending reports for senior site management. Ensure site Lot Release/Disposition goals are met and system health is maintained. Sponsor and develop a lean culture, driving continuous improvement of our quality processes. Provide general direction for the department, developing team goals and ensuring continuous improvement. Conduct regularly scheduled meetings with staff to review objectives, provide support, feedback, and resolve issues. Participate in the hiring process, provide performance feedback, and support career development. Perform other duties as assigned, including reviewing and approving various documents (e.g., Product Quality Reports, Quality Agreements, Deviation Reports, filing reviews) and lot disposition. Key requirements
Bachelor’s Degree or equivalent experience. 5-10 years of related experience in Quality Assurance Operations. Proven track record to lead and manage a team optimally. Strong understanding of cGMP regulations and compliance requirements. Excellent communication and interpersonal skills. Ability to work collaboratively with cross-functional teams. Strong problem-solving skills and attention to detail. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, protected veteran status, or any other characteristic protected by law.
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Associate Director, Quality Assurance Operations - LSA – United States, Portsmouth (New Hampshire). Lonza offers the opportunity to lead central initiatives to boost quality standards and ensure cGMP compliance. Key Responsibilities
Own the overall quality strategy across Manufacturing Operations. Provide general direction and support, acting as a point of escalation for Quality Assurance staff and customers. Ensure objectives are met and align with customer Quality Agreements, Lonza SOPs, and regulatory requirements. Partner with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to resolve high-risk issues with Change Controls, Deviations, CAPA, and Investigations. Attend and/or co-chair Change Control Committee, Deviations Review Board, and CAPA Board meetings. Support customer audits and regulatory inspections. Manage and supervise Key Performance Indicator Quality Metrics, including monthly/quarterly deviation trending reports for senior site management. Ensure site Lot Release/Disposition goals are met and system health is maintained. Sponsor and develop a lean culture, driving continuous improvement of our quality processes. Provide general direction for the department, developing team goals and ensuring continuous improvement. Conduct regularly scheduled meetings with staff to review objectives, provide support, feedback, and resolve issues. Participate in the hiring process, provide performance feedback, and support career development. Perform other duties as assigned, including reviewing and approving various documents (e.g., Product Quality Reports, Quality Agreements, Deviation Reports, filing reviews) and lot disposition. Key requirements
Bachelor’s Degree or equivalent experience. 5-10 years of related experience in Quality Assurance Operations. Proven track record to lead and manage a team optimally. Strong understanding of cGMP regulations and compliance requirements. Excellent communication and interpersonal skills. Ability to work collaboratively with cross-functional teams. Strong problem-solving skills and attention to detail. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability status, protected veteran status, or any other characteristic protected by law.
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