Quality Assurance Compliance Officer in Carlsbad, CA at Apex Life Sciences

Date Posted: 3/3/2018

Job Snapshot

Job Description

Our Client, a biotechnology product development company, is seeking an experienced Quality Assurance Compliance Officer to join their expanding team.

The Design Compliance Engineer will be part of New Product Introduction (NPI) Core Teams responsible for quality oversight and approval of development records for the product design history. The engineer will participate in project team meetings, design review activities, and lead the product risk management activities for the project. A stage gate process will be followed and enforced by the compliance engineer from product concept, to feasibility, design transfer, and final launch to the market.  


  • Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.
  • Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products.
  • Assess product regulations and standards impact to meet global requirements Provide leadership to sites to ensure global product compliance requirements are understood.
  • Advise Divisional and BU leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk
  • Work closely with new product introduction teams to meet compliance requirements on schedule
  • Ensure all necessary compliance documentation is current and available upon request.
  • Oversee the operations of the design compliance group to ensure accurate results, adherence to Company protocols, and timely completion of projects. Interface with corporate partners regarding quality issues, audits, and special projects.
  • Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards. Prepare and/or review documentation required for regulatory submissions.
  • Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
  • Actively lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Quality Control organization.
  • Lead the group of approximately 20 people to meet corporate goals. This position is responsible for other duties as assigned.

Minimum Requirements/Qualifications:

  • Bachelor’s degree in a Technical or Engineering discipline required.
  • Experience implementing Design for Compliance and training programs.
  • Experience with Lab/ IVD/ Medical equipment is preferred. Excellent interpersonal and communication skills with ability to effective interface with technical personnel at various levels of the organization.
  • Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within pharmaceutical Quality Control.
  • Strong knowledge of regulatory guidelines and their application.
  • Excellent written and verbal communication skills.
  • Ability to act quickly and decisively.