Sr. Director of Quality Assurance in Amityville, NY at APEX Systems

Date Posted: 10/16/2019

Job Snapshot

Job Description

Job #:  988653

Sr. Director of Quality Assurance
The Director of Quality Assurance and Continuous Improvement aims to ensure that the company meets both external and internal requirements, regarding product and process quality.  This position develops and implements the activities required to meet quality standards and is responsible for ensuring that FDA standards and company specific requirements are met and integrated into a Total Quality Management (TQM) Program which executes Quality By Design (QBD) and Continuous Improvement.  The Director of Quality Assurance also sets and maintains standards for quality measurement, acceptance and rejection of finished goods, bulk product, packaging components and raw materials.  They will also interface directly with FDA under the guidance of the management team.
  • Oversee/Manage the Quality Assurance department
  • Administer/oversee Internal Audits.
  • Administer/oversee External Manufacturer Audit Surveys.
  • Administer/oversee data collection from production, labeling and field inquiries regarding quality
  • Advise and implement on matters related to Good Manufacturing Practices.
  • Chair or advise Technical Advisory Committee on regulatory matters.
  • Oversee the review of labels and ancillary printed materials for regulatory compliance.
  • Oversee the review of reports related to Annual Product Review.
  • Review reports related to customer complaints
  • Manage day-to-day operations of quality control department.
  • Oversee the GMP review for products related to Adverse Product Reactions.
  • Oversee the preparation of customer driven Deviation Reports.
  • Oversee internal Deviation Reports and related investigation.
  • Participate/Assist as required in Out of Specifications Investigations and Deviations initiated by other departments.
  • Write Standard Operating Procedures (SOP).
  • Oversee annual review of deviation reports
  • Oversee annual review of non-conformance reports
  • Oversee SOP training.
  • Assure compliance with customer SOPs.
  • Build a Continuous Improvement program and culture across the company and its operations.
  • Quality liaison for contract accounts. 
  • Promote quality achievement and performance improvement throughout the organization (TQM).
  • Approving standards and establishing clearly defined quality methods for staff to apply.
  • Setting up and maintaining organized controls and documentation procedures
  • Supervising quality assurance personnel in carrying out tests and checks.
  • Develop clear understanding of various processes involved in all aspects of the production cycle to ensure proper quality measures are employed.
  • Oversee Non-Conformance reports
  • Communicates with all departments to ensure the QA process is followed.
  • Must stay current on FDA standards that pertain to skin care products.

  • 10+ years of supervisor/management experience in OTC pharmaceutical and//or pharmaceutical cosmetics
  • Prior experience with topical products a plus
  • Experience working directly with the FDA on audits
  • BS degree in chemistry/biology

FOR IMMEDIATE CONSIDERATION Please e-mail your resume to Marshena Moncrieffe at and contact our office at 914-683-5700 regarding the Sr. Director of Quality Assurance Position
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.