Lonza
SeniorQualitySystems&ComplianceProjectManager
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“Senior Quality Systems & Compliance Project Manager at Lonza. Skills: Quality Systems, Compliance, Project Management. Lead Quality QMS & Compliance projects. Drive proactive maintenance and development of Quality System”
What You'll Achieve.
Achieve sustainable compliance; Achieve site compliance goals
Industry & Context.
Ability to analyze data and extract the essence to drive change
What They're Looking For.
Must Have
Bachelor's or master’s degree in Life Sciences, Engineering or related field, Advanced experience in biopharmaceutical manufacturing experience and/or quality operations, plus quality systems working in a GMP environment, Experience with regulations (US, EU and other), Experience in a biopharmaceutical manufacturing environment or other relevant experience such as industries with high reliability needs, Experience in managing complex business setups and projects
Nice to Have
An additional background in business administration, project management, and Lean/Six sigma management is a plus
What You'll Do.
Lead Quality QMS & Compliance projects
Drive proactive maintenance and development of Quality System
Achieve sustainable compliance
Lead Compliance program at the site
Manage outputs from risk assessments
and quality escalations
Identify necessary QMS and Compliance projects
Drive improvements with functional areas
Achieve site compliance goals
Lead the implementation Quality improvement projects
Improve Quality performance and Compliance
Lead follow-up assessment from Health Authority
customer and internal audit observations
Lead lessons learned sessions
Implement inspection readiness actions
Train workforce on inspection readiness needs
Implement new or revised global Compliance programs and standards
Partner with functions to implement a Quality culture program
Scope & manage projects for QMS and Compliance needs
Partner closely with all assets and functions
Ensure proper deviation trending
Ensure root cause analysis is established
Ensure CAPA effectiveness is implemented
Act as a partner to Manufacturing Operations teams
Act as a partner to supporting teams
How You'll Work.
Team & Collaboration
Partner with functions at site to implement a Quality culture program; Partner very closely with all assets and functions; Act as a partner to the Manufacturing Operations teams; Act as a partner to other teams that support operations
Process & Methodology
Manage projects that focus on QMS and Compliance needs, Manage complex business setups and projects
Full Job Description
**_Senior Quality Systems & Compliance Project Manager _** **Location:** This is an on-site position located in Pearland, TX The purpose of this role is responsible for leading Quality QMS & Compliance projects with the objective to drive a forward looking and proactive maintenance and development of the Quality System, through simplification of processes and to achieve sustainable compliance. Will Lead the Compliance program at the site and ensure continued input through data readouts from inspections, audits (internal and global), regulatory intelligence, investigations, deviations, complaints etc. Responsible to manage the outputs from the risks assessments, audits, and quality escalations to help identify the necessary QMS and Compliance projects for the site; and to drive with the functional areas the necessary improvements to achieve the site compliance goals. **What you will get:** A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: * Performance-related bonus. * Medical, dental and vision insurance. * 401(k) matching plan. * Life insurance, as well as short-term and long-term disability insurance. * Employee assistance programs. * Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. **What you will do:** * Identifies and leads the implementation Quality improvement projects to improve Quality performance and Compliance at the site. * Leads follow-up assessment from Health Authority, customer and internal audit observations from the Lonza network or from regulatory intelligence. * Leads lessons learned sessions from case studies from Lonza Houston and the Lonza Network. * Implements inspection readiness actions and trains the Houston workforce on inspection readiness needs. * Is responsible for implementation of new or revised global Compliance programs and standards at Lonza LHI. * Partner with functi
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