Head Of Quality Assurance

Company: Pharmasol Corporation
Location: Boston
Posted on: August 7, 2022

Job Description:

The Vice President of Quality & Regulatory Affairs is head of quality for the company, overseeing quality assurance and quality control, managing the total compliance function. -The VP of Quality will be responsible for ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal regulations.
MAJOR DUTIES AND RESPONSIBILITIES:--- - - - - - - -Design, implement and maintain (GxP) QA and QC programs, and the compliance infrastructure. This includes the SOP system, training programs, and performing internal and external audits.--- - - - - - - -Lead and manage inspections by FDA, other regulatory agencies and commercial partners.--- - - - - - - -Coordinate with regulatory agencies and other external auditors to build trust and confidence in company quality systems.--- - - - - - - -Lead quality input on contracts and serve as the primary contact for the negotiation of quality agreements.--- - - - - - - -Work with the company's external suppliers including contract labs to ensure consistent quality and compliance.--- - - - - - - -Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GXP regulations.--- - - - - - - -Oversee compliance (GMP and GCP) auditing program to fulfill regulatory requirements.--- - - - - - - -Develop, manage, and monitor adherence to the overall Quality and Compliance budget.--- - - - - - - -Develop, analyze, and report business metrics and highlights.--- - - - - - - -Review trends and report to executive management on regular basis--- - - - - - - -Ensure Annual Product Reviews are performed and provided to clients ---- - - - - - - -Ensure corporate calibration and maintenance program is followed
ORGANIZATIONAL RELATIONSHIPS: ---- - - - Reports indirectly to the President--- - - - Supervises, trains, and assists all quality personnel--- - - - Directs quality related activities with Operations, Warehousing, Purchasing and Customer Service. - -
EXPERIENCE AND/OR EDUCATIONAL REQUIREMENTS:--- - - - Bachelor's Degree in Science or a related field; advanced degree strongly preferred--- - - - 12+ years' experience in the pharmaceutical or biotechnology industry in a quality or compliance--- - - - - - - -2+ years' experience as a functional head of a quality department--- - - - - - - -Strong GxP knowledge in the pharmaceutical industry--- - - - - - - -Hands-on experience with implementing and managing Quality/Compliance systems and processes (infrastructure)--- - - - - - - -Proven record of developing and maintaining successful working relationships with regulatory agencies
5. - - - - - -PHYSICAL REQUIREMENTS--- - - -None

Keywords: Pharmasol Corporation, Boston , Head Of Quality Assurance, Accounting, Auditing , Boston, Massachusetts