Director, QA

Job Locations US-IL-LAKE FOREST
ID
2021-1137
Category
Sales
Type
Regular Full-Time

Overview

The Director of QA is responsible for the development, implementation, and management of Assertio's internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance.  The Director will oversee and approve quality standards related to the manufacturing, testing, and release of commercial drug products and clinical trial supplies. The Director is also responsible for interacting successfully with Executive Management, other department heads, external suppliers and service providers to ensure manufacturing compliance and release of API, commercial drug products, and clinical supplies. The Director is the primary interface with FDA and other regulatory agencies on quality issues and during inspections.

Responsibilities

Essential Functions

  • Ensure the efficient operation of the Quality Assurance Lead and mentor department staff, including training, employee development and performance evaluations.
  • Act as the company authority for the interpretation of GMP regulations and guidance documents related to pharmaceutical drug product
  • Primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs, and
  • Responsible for setting quality policy and approving GMP standards, including but not limited to: policies, procedures, analytical methods, product specifications, master batch records, raw material and API specifications, and validation
  • Responsible for the dispositioning of drug product (commercial and clinical)
  • Responsible for the design, management and continuous improvement of all quality systems within a QMS platform. These systems include change control, deviations/investigations, CAPA, complaint handling, returned goods, vendor management, quality agreements, document/records control and archive, and GMP
  • Responsible for QA oversight and approval of validation protocols, programs, and reports for the following: process, cleaning, equipment, analytical methods, shipping, and computerized
  • Manage internal and external audit programs for all GXP

Qualifications

Education/Experience

  • BA/BS degree or equivalent experience in related field required. Advanced degree preferred.
  • Minimum 10 years’ experience in GMP environment with at least 8 years QA experience
  • Experience with manufacturing commercial pharmaceutical products is required
  • Prior experience with outsourced GMP activity strongly desired
  • Experience with combination products a bonus
  • Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required

Physical Requirements

  • Ability to operate a motor vehicle
  • Ability to travel via airplane
  • Ability to sit for long periods of time
  • Ability to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal.
  • Reaching: Extending hand(s) and arm(s) in any direction.
  • Standing: Remaining upright on the feet.
  • Pushing: Using upper extremities to press against something with steady force in order to thrust
  • Lifting: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position of up to 20 lbs. on occasion

 Mental Requirements

  • Ability to prepare and analyze data and figures
  • Ability to understand, remember and apply oral and written instructions
  • Ability to organize and prioritize own works schedule
  • Ability to apply common sense in performing job
  • Ability to understand and follow instructions

Accommodations for Applicants with Disabilities

Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email hr@assertiotx.com or call 224-441-6867 for assistance.

 

For more information about your EEO rights as an applicant under the law, please click here.

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