Principal Auditor, Enterprise Quality Auditing

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Independently organizes and performs quality audits for Endo’s Branded Pharmaceuticals. The audits include suppliers/vendors, third parties, Endo’s business units and internal manufacturing sites that support marketed drug products to ensure products, controls, policies and processes meet Pharmaceutical/Biotechnology industry quality standards. Leads Pre-Approval Mock Inspections to prepare CMO facilities for regulatory inspections and assesses gaps in the quality systems and overall infrastructure.  Leads or provides guidance for cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards. May interact directly with regulatory authorities during regulatory inspections. Evaluates metrics to determine trends and opportunities for continuous improvements. Has extensive experience and technical expertise in over 10 audit areas, such as API, Microbiology Laboratories, Sterile Drug Product, Contract Packaging, Mock PAI, etc.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - Audits Endo’s Branded Pharmaceuticals business units, internal manufacturing sites and related suppliers/vendors and third parties.

Job Description

Key Accountabilities

Auditing = 85%

• Manages the auditing metrics program which involves tracking audit responses and auditee’s CAPAs until completion and closeout.
• Manages audit activities which include audit agendas, audit reports and communicates finding to external and internal stakeholders.
• Performs evaluations of quality systems and practices to identify potential problems such as non-conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.
• Supports the audit program by independently conducting internal and external audits or participating as an audit team member.
• Contributes to the development of the annual audit plans and schedules.
• Collects, collates and evaluates applicable key auditing performance parameters for metrics report generation and presentation to management and stakeholders.

EQA Department Support = 15%

As related to Enterprise Quality Auditing Functions:

• Is responsible for the development and implementation of EQA programs, policies, procedures, agreements & controls.
• Leads Mock PAIs of CMOs to prepare the facilities for audits and assess gaps in the system.
• Organizes and leads periodic audit review meetings.
• Provides guidance for continuous improvement to ensure compliance with regulations and current industry standards.
• Evaluates metrics to determine trends and opportunities for continuous improvements.
• Assists in FDA inspections and may interact with regulatory authorities during regulatory inspections.

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Minimum of a BA/BS with a minimum of 10 years’ experience in a pharmaceutical manufacturing or Quality Assurance/Compliance environment.
• ASQ-CQA or ASQ-CQE certified highly desired.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Possesses strong technical and quality/compliance background related to pharmaceuticals/biologics.
• Possesses thorough knowledge of current domestic and international standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.

Skills & Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Has extensive experience and technical expertise in over 10 audit areas, such as API, Micro Lab, sterile drug product, Contract Pkg., Mock PAI, etc.
• Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents
• Demonstrates the ability to conduct GMP audits of drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.
• Demonstrates the ability to conduct focused quality incident investigations.
• Able to use Word, Excel, Power Point and Outlook.
• Excellent communication skills, both written and verbal.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Walk across factory / warehouse.
• International Travel (45%).

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.