19 days old

Senior Manager, Data Integrity

US05 Lonza Houston Inc.
Houston, TX 77002
  • Job Code

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, theres no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And thats the kind of work we want to be part of.

Lonza in Houston, TX (Pearland) is looking for an experienced Data Integrity Senior Manager. This role will manage the Good manufacturing practices (GMP) Data Integrity Governance program across product lifecycles for assurance with regulatory and compliance requirements with GMP, electronic record and electronic signature (ERES), and Data Integrity. You will provide oversight for the governance; management and coordination of activities related to the Data Integrity Governance Program include directing, developing, and maintaining Data Integrity compliance across the site and internal functions in alignment with global GMP and ERES (FDA 21 CFR Part 11 and EMA Annex 11).

Additionally, you will have responsibility for development and implementation of appropriate procedures and process to support the data integrity function for the site. The role will support senior Quality Assurance (QA), Quality Control (QC) and Validation leadership in decision making to ensure regulatory compliance and recommend appropriate corrective actions where needed, from a Data Integrity standpoint.

Key responsibilities:

  • Develop and execute plans, procedures and requirements to address data integrity system gaps for GMP applications and ensure compliance for the Pearland site.

  • Assist in development of site related data integrity training materials to provide guidance, training, and support to site personnel.

  • Identify and complete Data Integrity-related deliverables and activities as related to Global SOPs and current regulations for pharmaceutical facilities, utilities and site specific systems both computerized and paper based.

Key requirements:

  • Bachelor Degree in Computer Science or Management Information Systems or equivalent related industry discipline.

  • Advanced level working experience in Quality Assurance, Quality Control or Computer System Validation within the Pharmaceutical industry.

  • Working knowledge of computerized systems utilized in pharmaceutical manufacturing, utilities, and QC test equipment.

  • FDA inspections experience.

  • Excellent verbal, presentation, and written communication skills.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Posted: 2019-11-25 Expires: 2019-12-24
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Sponsored by:
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Senior Manager, Data Integrity

US05 Lonza Houston Inc.
Houston, TX 77002

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