Head of Sterility Assurance

Lonza•Houston, TX

3d•Onsite

About The Position

The purpose of this role is to ensure implementation of all aspects of the sterility assurance program in accordance with the Lonza and regulatory standards and specifically the new product introduction and process lifecycle requirements. While working closely with site stakeholders, this position will focus on the sterility assurance culture, operations and awareness to improve the batch success rate and contamination control. Additionally, this position works with the Global Quality Head of Sterility Assurance and MSAT Sterility Assurance Lead to assure alignment and consistency at LHI.

Requirements

Strong understanding of USP and EP, endotoxin, and sterility testing is required.
Comprehensive understanding of the major Regulations and Guidelines pertaining to the pharmaceutical industry. Specifically GMP compliance knowledge including 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing; ISO 9001:2015, 13485 and Part 11 compliance.
Hands-on experience in complex investigations in both preventive and reactive contamination control.
Knowledge and experience in microbiological test technologies, efficacy studies and recovery methods.
Strong regulatory understanding of environmental monitoring programs that can will enable proactive assessment of controls prior to exceeded action limits.
Technical knowledge of clean room engineering including particle control mechanisms.

Responsibilities

Accountable for the compliant, effective and modern contamination control strategy across LHI.
Accountable for the implementation of an effective sterility assurance program across LHI.
Acts as oversight for Sterility Assurance improvement projects.
Support stakeholders and specialists to share/create best practices thereby ensuring consistency and effectiveness of contamination control.
Ensure operational activities are in line with cGMP expectations.
In consultation with Site and Global stakeholders, maintain and update the aseptic education and awareness training program to ensure aseptic sustainability.
Provides sterility assurance expertise on facility designs, flows, zone concepts, investigations, and new product introductions/tech transfers to meet global and regulatory requirements from an early stage.
Continuously performs global review and alignment on best practice. Includes: Aseptic behavior, Sterilization, APS, Material controls, Clean room management, Cleaning and Disinfection, Cross contamination, Supplier management for critical suppliers.
Provides support for preventive and corrective efforts as a result of critical investigations, audit and inspection findings to improve Sterility Assurance.
Works with global and site QC microbiology (as well as contract testing labs) on Sterility Assurance topics such as sterility test failures and EM excursions.
Works with the Global Technical Functions and Global Quality reviewing and aligning on best practice in contamination control.
Perform/Review Contamination Risk Assessments (RA) to harmonize standards across the site and assets to ensure uniformity with the ability to articulate technical aspects of completed RA.