Endo International Senior Quality Specialist, Compliance in Chestnut Ridge, New York

Job Summary - a concise overview of the job

The Senior Quality Specialist, Compliance is responsible for independently planning and conducting activities that ensure the plant’s compliance to cGMPs and regulations as well as internal quality procedures. Supports quality efforts across the Company and the Endo enterprise to ensure a state of constant readiness for inspections at the site. In order to maintain preparedness, this role audits and assesses the performance of the facility against regulations and internal requirements. Identifies compliance issues and support the implementation changes for constant improvements. Ensures adherence to SOPs and policies and assists the Compliance Manager in ensuring that procedures reflect current practice.

Provides subject matter expert (SME) consultative support for all regulatory audits, internal and external inspections, and other audits. Leads cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards. Implements a self-inspection program and evaluates metrics to determine trends and opportunities for continuous improvements and liaises with QS&T and other departments.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Scope is one business unit. Responsible for working to ensure compliance at the site.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Compliance

§ Independently audits and evaluates quality systems and practices to identify potential problems and coordinate resolutions

§ Implements a self-inspection program to include inspection of procedures, audit schedules, audit reports and observation follow-up and closure

§ Provides guidance on quality/compliance improvements

§ Prepares summaries and reports based on internal audits, outlining improvements and performance against audit findings

§ Ensures adherence to SOPs and policies

§ Ensures that procedures reflect current practices and policies

§ Reviews documents for compliance to current regulations and cGMPs

40%

Inspection Readiness

§ Provides SME consultative support for all regulatory audits, internal and external inspections, and other audits

§ Maintains FDA Readiness Plan for the facility

§ Plans and participates in mock inspections to prepare the facility for audits and assesses gaps in the system

30%

Continuous Improvement

§ Leads cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards

§ Evaluates metrics to determine trends and opportunities for continuous improvements and liaises with QS&T and other departments

20%

Management Review

§ Provides accurate metrics to the QS&T department

10%

Total

100%

Qualifications

Education & Experience

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

§ Minimum of BA/BS preferably in life sciences with a minimum of 6+ years’ experience in the pharmaceutical industry

§ Auditing experience against cGMP

§ Regulatory Inspection experience required

e 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.

§ Strong knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA

§ Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines

§ Technical and quality background related to pharmaceuticals

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.

§ Ability to lead cross-functional projects

§ Ability to plan and participate in mock inspections

§ Strong communication skills

§ Strong focus on quality and proven ability to apply a high degree of integrity

§ Customer/Stakeholder focused (understand business plans and operating environment)

§ Technical Writing ability

§ Clear problem-solving and decision-making skill

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 plant/warehouse

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.