The Quality Assurance Manager leads a team of QA Specialists responsible for directly supporting manufacturing operations including responding to QA Hotline calls, triaging process events/deviations, observing and coaching GMP behaviors, approving Quality TagOuts and review of executed electronic batch records. The Manager ensures staff is meeting objectives and deliverables on time and in full, and may perform key functions such as lot release and co-chair of the Deviation Review Board, CAPA Review Board and Change Control Committee. This position supports the overflow of tasks as needed to ensure deliverables are met. The manager assigns the resources and priorities for the team, ensures adequate training, coaches and develops staff, and evaluates performance. Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.

• Experience managing direct reports and demonstrated ability to mentor and coach to achieve common goals
• Strong experience in a GMP environment
• Biotechnology manufacturing background is preferred
• Deep knowledge of GMPs and regulations.
• Demonstrated quality decision making skills
• experience with TrackWise, SAP, Syncade and Microsoft suite of products is preferred
• Self-motivated person with excellent written and verbal communication skills to all levels, ability to tolerate challenging workloads and changing priorities.
• Provides general direction and support and acts as a point of escalation for QA and Operations staff.
• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Identifies and implements improvements to quality processes.
• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and PP&L) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
• May attend and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings. May attend Site Quality Council and Lot Disposition meetings.
• Manage and track Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.
• Performs Lot Release/Disposition activities
• Provides general direction for department. Develops team goals, monitors progress and ensures continuous improvement.
• Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.
• May participate in the hiring process, provides performance feedback, coaches, mentors and supports career development.
• Supports Regulatory and Customer Audits as needed.
• Perform other duties as assigned.
• Strong attention to detail is required
  

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, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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