Head Of Quality Assurance
Company: Pharmasol Corporation
Location: Boston
Posted on: August 7, 2022
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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
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