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 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).
What we are looking for:
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.
An additional background in business administration, project management, and Lean/Six sigma management is a plus.
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.
About Lonza:
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Skills Required
- Bachelor's or master's degree in Life Sciences, Engineering or related field.
- Advanced experience in biopharmaceutical manufacturing and/or quality operations and quality systems in a GMP environment.
- Experience with US, EU, and other regulations.
- Experience managing complex business setups and projects.
- Ability to analyze data and extract insights to drive change.
- Background in business administration, project management, and Lean/Six Sigma management.
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
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