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Director, Quality & Regulatory Compliance

at ILC Dover in Frederica, Delaware, United States

Job Description

Job Summary:

The Global Director, Quality Operations, PharmBio is responsible for providing quality leadership across the PharmBio manufacturing plants to ensure that products that are produced are compliant to site and global standards. The role will provide expertise and direction to the onsite Quality teams and ensure successful production of products across the sites globally. This critical leadership position will instill ownership and accountability for the site quality objectives across the organization, through the continued development of high performing onsite teams, with a passion for servant leadership for both our internal and external customers of the products we deliver to the market.

Position Objective:

The Global Director, Quality Operations, PharmBio position is in place to drive harmonization across the sites around all Quality Management System (QMS) elements including CAPA, Deviation, Change Management, Training, etc. The role will provide leadership to the site Quality teams in order to drive continuous improvement and accountability on all quality operations deliverables to ensure a safe and compliant product for our customers.

*Essential Job Responsibilities:

  • Provides strong leadership and guidance to the onsite Quality Site Managers across the portfolio of sites within the PharmBio network.
  • Accountable for the implementation of the quality control and quality assurance requirements across the entire product lifecycle of products within the PharmBio portfolio.
  • Establishes quality metrics across the sites and uses data analytics to report out on the progress across all established measures.

Qualifications:

  • Bachelor of Science or equivalent degree program in Science, or a quality related discipline.
  • 12+ years’ experience in regulated Quality, including experience in both Quality Control and Quality Assurance and 8 years’ experience specific to management responsibility.
  • Knowledge in applicable regulations (ISO 9001, ISO 13485, 21 CFR 820, 210, 211)

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

Applicants with a disability that need assistance applying for a position may email hr@ilcdover.com

Apply Here: https://www.click2apply.net/BDzONpHALkoqZUjxQSPllo

Equal Opportunity Employer, including disability/protected veterans

PI241034165 

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Job Posting: 1277541

Posted On: Jun 12, 2024

Updated On: Jul 03, 2024

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