Senior Quality Systems & Compliance Project Manager

Lonza•Houston, TX

8d•Onsite

About The Position

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.

Requirements

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.
Ability to analyze data and extract the essence to drive change.
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 Haves

An additional background in business administration, project management, and Lean/Six sigma management is a plus.

Responsibilities

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 functions at site to implement a Quality culture program.
Scope & manage projects that focus on QMS and Compliance needs, as required at Lonza Houston site.
Partner very closely with all assets and functions and ensure proper deviation trending and root cause analysis from observations is established in full and CAPA effectiveness is implemented in full.
Act as a strong partner to the Manufacturing Operations teams (Viral Vector & Cell Therapy) and other teams that support operations (e.g. QC, Materials Management, Engineering, Validation and Quality Systems).