QA Project Leader

Job Summary

Responsibilities

• Serve as a change agent performing project management duties (PMO).
• Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team.
• Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities.
• Provide progress reports, assist in removing barriers, and escalate issues when additional support is needed.
• Manage projects that primarily focus on compliance or continuous improvement / simplification category.
• Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT).
• Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management.
• Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements.
• Consolidate quality metrics and reporting in collaboration with respective QA reporting heads.
• Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
• Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors.
• Prepares and presents progress reports for senior management.
• Identify and resolve emerging issues that may impact project or corporate goals.
• Recognize potential threats to project success and elevate issues to senior management.
• Develop and implement contingency plans.
• All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.

Requirements:

• Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
• Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.