Quality Systems Project Manager

📋 Description

• Assist the owner of the Quality Risk Management Quality System in coordinating projects related to strategic initiatives.

• Ensure adherence to regulatory standards, industry guidelines, and company policies.

• Examine QMS trends and KPIs to uncover opportunities for ongoing enhancement.

• Aid the Quality system owner in activities related to compliance.

• Manage, monitor, and/or facilitate the fulfillment of CAPAs, inspection/audit commitments, and more.

• Help in drafting and updating SOPs, work instructions, and training documents.

• Provide administrative assistance to the Global Quality systems team.

• Work in collaboration with cross-functional teams to ensure the prompt and compliant execution of Quality Risk management tasks.

⛳️ Requirements

• Bachelor's degree in technology, engineering, life sciences, or a related field, or equivalent experience.

• 5+ years of relevant professional experience, or an equivalent combination of education and experience.

• Proven experience in supporting Quality Risk Management across various GxPs.

• Project management certification is desirable.

• Familiarity with lean six sigma, risk assessment tools, and DMAIC methodologies.

• In-depth understanding of GxP regulations and concepts pertinent to Quality Systems management, particularly Quality Risk Management.

• Background in a GxP regulated environment focusing on Quality Systems, Compliance, Data Quality, or Quality Operations roles.

• Experience with data visualization tools.

• Well-informed about industry standards and best practices concerning data analysis and reporting.

• Ability to collaborate effectively with cross-functional teams.

• Strategic, critical, and analytical thinking skills.

• Excellent oral and written communication abilities to convey complex information clearly.

• Capacity to identify and proactively seek necessary information.

• Detail-oriented, with a proven capability to independently plan and execute data analysis.

• Experience in project management and familiarity with PM software.

• Proficient in Microsoft Office Suite (PowerPoint, Teams, Word, Excel, Outlook).

🏝️ Benefits

• Compensation, medical benefits, and additional fringe benefits.

• Overtime pay in accordance with federal and state regulations.