Sr. Manager - TSMS Validation at Eli Lilly and Company

Sesto Fiorentino, Tuscany, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Master’s Degree in Technical/Scientific disciplines
Fluent in both Italian and English
Minimum of 7 years of experience in validation, equipment qualification, or related pharmaceutical/manufacturing roles
Previous experience in people management, preferably with cross-functional groups within a matrix organization
Proven communication and team coordination skills, troubleshooting ability, and experience in interactions with regulatory authorities
Managerial capabilities in team leadership, including selection, recruitment, development, and growth of professionals and technicians
Position requires working on-site and includes 4 days of remote work per month

Responsibilities

Oversee initial qualification activities for new equipment and manage Periodic Validation of existing equipment, including periodic review of qualification status
Ensure adherence to the Validation plan, coordinating internal and external resources as needed
Manage the department’s Capital budget, ensuring adequacy of technology and equipment through the acquisition of new tools and periodic review of existing ones
Maintain and oversee TSMS documentation within Quality Docs and LRM2 systems, either personally or through team members
Lead and coordinate all activities of a complex team, ensuring operational efficiency and compliance
Guarantee execution of Periodic Validation and Cleaning Validation for equipment, minimizing impact on production activities and coordinating qualified personnel
Ensure preparation of documentation for periodic review of equipment qualification status
Manage TSMS laboratories and instruments, ensuring they are maintained in optimal condition
Collaborate on Capital budget management for the acquisition of inventory materials within available funds
Drive the identification and introduction of new technologies and innovations for validation and qualification tools
Act as department representative for Quality Docs and LRM2, ensuring proper maintenance and periodic verification of electronic and paper validation documentation
Chair the TSMS Safety Team, ensuring coverage of all TSMS activities
Participate in network activities related to periodic validation and preparation/use of reference tools

Skills

Validation

TSMS

Sterility Assurance

Equipment Qualification

Cleaning Validation

Quality Docs

LRM2

Capital Budget Management

Team Leadership

Compliance

Periodic Review

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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