Lead BQA - GMQO at Eli Lilly and Company

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Act as a quality consultant and leader in integrating quality requirements into business processes
Implement the quality plan and ensure consistency between global and local requirements
Implement quality systems and assure alignment with appropriate quality and regulatory requirements
Act as contact person for quality and business process compliance concerns with IT Systems in clinical data flow
Consult with supervision regarding actual job responsibilities and related duties

Responsibilities

Ensure local implementation of the Safety and Efficacy Quality System (SEQS)
Review regional and/or local SOPs versus global policies; review quality system documents and provide feedback
Recommend new procedures or changes to existing procedures where applicable
Provide quality oversight for compliance to SEQS
Escalate compliance issues to management locally and globally as appropriate
Ensure inspection readiness and compliance to global, regional, and/or local regulations
Assist in interpreting relevant pharmacovigilance regulations and guidelines; act as contact person in regional center and/or affiliates
Perform quality self-assessments
Facilitate audits and inspections
Coordinate audit responses including Trackwise system documentation
Communicate and ensure inspection readiness requirements are in place (e.g., organization and availability of documents such as training records, job descriptions, backroom and/or front room organization)
Ensure implementation and maintenance of regional and/or affiliate Quality Plan(s)
Document regional and/or affiliate quality systems requirements ensuring clear accountabilities
Manage the regional and/or affiliate quality plan(s); provide updates to quality and business owners
Provide consultation on integration of quality into business processes
Support the business on application and facilitation of quality systems (deviations, notification to management, change control)
Consult on root cause analysis for deviations
Drive trending of metrics to improve processes and compliance
Analyze trends, identify areas of weaknesses/gaps, and recommend corrective actions
Monitor completion of deviations, CAPA related to deviations, and change controls
Monitor completion of audit responses through metrics; provide updates to management
Share key learning to drive simplification and replicate best practices in the region and globally
Coordinate quality improvement initiatives
Seek and implement simplification

Skills

Key technologies and capabilities for this role

Quality AssuranceIT SystemsBusiness Process ComplianceQuality Systems StrategyRegulatory ComplianceBiometricsClinical Data FlowData AnalyticsStatistical Science

Questions & Answers

Common questions about this position

What is the employment type for this Lead BQA - GMQO position?

The position is full time.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What are the primary responsibilities of this BQA-Biometrics role?

Key responsibilities include ensuring local implementation of the Safety and Efficacy Quality System (SEQS), reviewing SOPs against global policies, providing quality oversight, escalating compliance issues, ensuring inspection readiness, facilitating audits and inspections, and coordinating audit responses.

What is the company culture like at Eli Lilly and Company?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and seeks determined individuals who give their best effort to discover life-changing medicines, improve disease management, and contribute to communities through philanthropy and volunteerism.

What makes a strong candidate for this BQA-Biometrics role?

Strong candidates should have expertise in quality systems, regulatory compliance, pharmacovigilance, and IT systems for clinical data flow, with the ability to act as a quality consultant, leader, and contact person for compliance concerns.

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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