Quality Compliance Manager
Qualitest Pharmaceuticals - Charlotte, NC

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The Quality Compliance Manager is responsible for planning, directing and conducting activities that ensure the plant’s compliance to cGMPs and regulations as well as internal quality procedures. The position will support quality efforts across the company and the Endo enterprise to ensure a state of constant readiness for inspections at the site. In order to maintain preparedness, the Compliance Manager will audit and assess the performance of the facility against regulations and internal requirements. The QCM will ensure adherence to SOPs and policies and ensure that procedures reflect current practice.

Key Accountabilities
  • Work with the plant and Endo Corporate to maintain compliance to regulations and procedures
  • Perform independent evaluations of quality systems and practices to identify potential problems and coordinate resolutions
  • Develop and implement a self-inspection program to include inspection of procedures, audit schedules, audit reports and observation follow-up and closure
  • Provide guidance on quality/compliance improvements
  • Supervise and support cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards
  • Prepare summaries and reports based on audits and inspections outlining improvements and performance against audit and inspection findings
  • Provide support for all regulatory audits, internal and external inspections and other audits
  • Assist in the evaluation of metrics to determine trends and opportunities for continuous improvements
  • Ensure adherence to SOPs and policies
  • Ensure that procedures reflect current practices and guidances
  • Maintain FDA Readiness Plan for the facility
  • Conduct Mock Inspections to prepare the facility for audits and assess gaps in the system
  • Review documents for compliance to current regulations and cGMP
  • Provide effective training for continuous improvement of employees
  • Assess training compliance to plant goals
  • Train employees on auditing processes
  • Develop and support the implementation of training processes to incorporate compliance and ensure accuracy to regulations and industry standards
  • Maintain knowledge of regulations, cGMPs and current industry standards and guidances
  • Serve as the SME for compliance
  • Accountable to manage and maintain GMP related licensing requirements for the site in collaboration with regulatory partners.
  • Serve as subject matter expert and collaborate with other departments to implement improvement and ensure compliance
  • Serve as Change Agent for continuous compliance improvement
  • Review investigations for compliance to regulations
Qualifications

Education & Experience
  • Bachelor of Science preferably in life sciences, physical sciences or other related field required
  • A minimum of 8 years of experience in a regulated industry (pharmaceutical, medical device, food)
  • At least 3 years’ experience auditing for FDA compliance
  • Prefer previous management experience in a regulated environment
  • Previous experience with CAPA and supplier quality desired
  • Auditing/Quality Certifications preferred (Certified Quality Auditor etc.)
Knowledge
  • Able to read and interpret FDA regulations
  • Knowledge of cGMPs
  • Auditing knowledge
  • Able to learn new procedures and regulations quickly

CareersInPharmaceutical.com - 15 months ago - save job - block
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