Quality Assurance Manager, Compliance

Position Description

Position Summary

This position is responsible for managing compliance with quality by departments and includes overseeing the Non-Compliant Event (a.k.a. discrepancy and complaints) program, the CAPA program, the change management program, and the risk assessment program.

Position Reports to

Director of Quality Assurance

Position Supervises

QA Associate, Compliance

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

  • Maintain work area in accordance with cGMPs
  • Assist with the reviewing and trending of environmental monitoring data
  • Coach, train, and serve as a resource for those supervised
  • Oversee the Assignment and Tracking of NCE’s
  • Work with respective departments relevant to issues being investigated in NCEs
  • Oversee the CAPA program
  • Oversee the risk assessment program
  • Oversee the change management program
  • Perform final release of clinical supplies as needed
  • Attend Quality Review Board meetings
  • Participate in client and health authority audits
  • Perform supplier/external and internal audits
  • Review equipment validation as necessary
  • Assist with oversite of Controlled Drug Substance handling at Xerimis
  • Assist with development, review and compliance with standard operating procedures, work instructions, data collection forms, policy documents and other documentation
  • Assist with driving change and implementing improvement in assigned areas
  • Create and revise documents in ZenQMS
  • Complete performance reviews
  • Other duties as assigned

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree or equivalent work experience
  • Excellent interpersonal skills
  • Excellent reading and writing skills
  • Excellent communication skills
  • Excellent problem-solving/investigational skills
  • English literacy
  • General mathematical skills
  • Computer literacy skills
  • Attention to detail
  • Effective time management skills
  • Strong Understanding of cGMPs
  • Familiarity with the pharmaceutical industry
  • Managerial experience

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is required to sit; stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl.  While performing the duties of this job, the employee is exposed to warehouse and operations (packaging) environments including regular exposure to elements such as odor, noise, dust, heat, cold or chemicals.  The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.  All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.  To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others.  The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.  This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

Apply Now

  • Max. file size: 50 MB.
  • This field is for validation purposes and should be left unchanged.