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Quality Assurance Compliance Manager
Quality Assurance Compliance ManagerClinLab Staffing • Newtown, PA, United States
Quality Assurance Compliance Manager

Quality Assurance Compliance Manager

ClinLab Staffing • Newtown, PA, United States
2 days ago
Job type
  • Full-time
Job description

QA Compliance Manager – Newtown, PA

The Compliance Manager is responsible for ensuring continuous compliance of investigational medicinal products with cGMPs and relevant regulations. This role will support the site self-inspection program, Health Authority inspections, perform general GMP readiness activities, and compliance initiatives, as necessary.

Key Duties & Responsibilities

  • Leading and supporting self-inspections and inspection readiness activities of new and existing manufacturing facilities, laboratories and support areas.
  • Lead and support internal audits and assessments to ensure compliance with relevant regulations.
  • Ensure compliance with applicable regulations, policies, and procedures.
  • Issue reports summarizing findings and tracks resulting CAPAs to satisfactory closure to maintain appropriate risk posture for the site. Notifies relevant management of unresolved issues or trends.
  • Develop and maintain metrics and key performance indicators to measure trends and improve quality performance. Perform trending reviews of observations and commitments, compile trend reports and present outcomes to management and governing Quality Councils.
  • Maintain an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Will provide guidance and interpretation of GMP, regulatory, and compliance standards.
  • Lead and support the preparation activities for GMP Compliance audits and Health Authority Inspections as needed.
  • Track audit and inspection commitments to closure.
  • Develop and harmonize procedures and processes that promote, facilitate and ensure compliance with domestic and international regulations and industry standards in support of the company’s objectives.
  • Proactively identify, develop and implement opportunities for work / process improvement and efficiency.
  • Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across multiple organizations to influence and implement solutions.
  • Represents Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.
  • Develop and maintain the supplier qualification program.
  • Evaluate testing procedures to, meet the specifications and regulatory commitments.

Education & Experience

  • BS degree in appropriate Science or related background
  • Minimum 10 years of experience in Quality Assurance / Compliance in the pharmaceutical, biopharma / biologics or related industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities or engineering preferred.
  • Familiarity with R&D or clinical supply areas and processes.
  • Sterile manufacturing experience and knowledge of US aseptic processing guidelines.
  • Ability to apply basic scientific and regulatory principles utilized to solve routine operational, and quality tasks.
  • Extensive knowledge of Good Manufacturing Practices (GMPs), US FDA and EU GMP regulations and ICH guidelines.
  • Demonstrated knowledge and direct experience with developing and establishing Quality Systems and GxP compliance within a regulated environment.
  • Experience leading internal and external audits.
  • Background in hosting and / or supporting US health authority inspections.
  • Strong leadership skills to lead cross-functional teams.
  • Extensive experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.
  • Proficient in PowerPoint, Excel, and Word.
  • Demonstrated experience using Quality Risk Management tools.
  • Excellent verbal and written communication and presentation skills across all levels.
  • Prioritize and manage multiple priorities and projects independently.

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    Quality Assurance Manager • Newtown, PA, United States

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