We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Performs general Quality Assurance (QA) activities including, but not limited to, internal and external audits and inspection support, SOP and policy development and oversight, deviation management and process improvement initiatives, and training implementation and compliance. The QA Auditor collaborates closely with operational teams and functional areas and reports directly to the Head of QA.

Responsibilities

• Provides Good Clinical Practice (GCP) consultation and overall quality assurance and compliance support to Lexitas project teams and operational staff to ensure that projects are conducted in accordance with sponsor protocols, SOPs, GCP, and appropriate guidelines and regulations
• Plans, conducts, reports, and oversees resolution of internal, investigator site, and vendor audits including directed audits
• Hosts and supports audits of Lexitas
• Supports regulatory inspections of investigator sites, sponsors, and Lexitas including on-site or remote inspection preparation/readiness activities
• Oversees investigation and management of suspected misconduct cases
• Manages the Quality Management System including development and revisions of SOPs, policies, and other controlled documents
• Evaluates policies and procedures for compliance with applicable regulations/guidelines and provides recommendations to management for continuous process improvements
• Leads or supports process improvement initiatives
• Supports corporate and project-specific training compliance
• Reviews and approves deviation management activities and documentation including investigations, root cause analysis, corrective and preventive action plans, and effectiveness check plans
• Compiles quality metrics
• Mentors and trains new QA team members
• Performs other duties, as assigned by management

Requirements

Education:

Required: A Bachelor’s degree in science or related field from an accredited college or university.

Experience:

A minimum of 8+ years of experience in the pharmaceutical industry with at least five years of direct experience in auditing and inspections, or equivalent combination of education and experience.

Skills:

• Thorough knowledge of GxP and global regulations
• Ophthalmology and information technology auditing experience preferred
• Auditor certification preferred
• Medical device and International Organization for Standardization (ISO) experience is a plus
• Ability to travel up to 50% of the time, including minimal international travel
• Excellent verbal and written communication skills
• Strong organizational and time management skills
• Flexible and able to prioritize competing demands/workload
• Ability to work independently with minimal direct supervision as well as in a team environment
• High degree of attention to detail and solid formatting, writing, and editing skills
• Strong negotiation, problem-solving, and conflict-management skills
• Proficient in Microsoft Office

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.