Agenus

GCP Sr QA Manager

US-MA-Lexington
Job ID
2017-1277
Category
Quality

Overview

Have a high level of knowledge and experience of appropriate GLP/GcLP compliance and other applicable regulations and laws, AGENUS procedures and appropriate AGENUS processes to conduct audits and provide expert advice to internal and external clients. To effectively lead, matrix manages, develop, and implement assigned projects. To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.

Responsibilities

The Sr Quality Assurance GCP Manager will set up and oversee GLP/GcLP compliance programs. This manager will be responsible for ensuring that associated external and internal entities (including GCP/GLP laboratories) and contract organizations meet all regulatory requirements.

  • Work independently and as part of the QA team.
  • Act as expert GLP/GcLP consultant to groups within the AGENUS organization.
  • Manage regular staff and consultants.
  • Train new and existing QA personnel.
  • Train and educate operational staff by the development and presentation of training courses.
  • Develop, implement and maintain QA systems and SOPs for GCP systems.
  • In liaison with the QA management team, promote compliance within the company and represent QA, as required.
  • Build, develop, and maintain good working relationships with internal and external customer groups.
  • Work with internal GCP customers and develop and execute strategic audit plans for the area.
  • In liaison with the QA management, matrix manage projects, including teams of multifunctional personnel, as needed.
  • Deputize for QA management within GCP area.
  • Review the work of the matrix team to ensure consistency and quality within the group.
  • Act as a contact with members of Regulatory Authorities and / or clients; help lead in inspections / audits, in agreement with QA management.
  • Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested.
  • Plan and conduct complex audits / mock inspections in agreement with QA management.
  • Review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.
  • Assist QA management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement.
  • Plan, track and oversee GCP audits of external contract laboratories and contract research organizations.
  • Plan track and oversee GCP internal audits against approved procedures.
  • Ensure compliance of clinical development/Clin Ops initiatives with all applicable regulations and standards.
  • Oversee all pre-clinical activities, review all audit reports and corrective actions generated from the audits.
  • Assist in resolving compliance issues at laboratory sites and laboratory vendors; and provide assessment of the impact of any deficiencies.
  • Maintain a database of all audit observations for quality analysis.
  • Identify and communicate all compliance risks to management.
  • Ensure review of analytical study reports, external publications, etc.
  • Participate in pre-clinical team meetings.
  • Participate in budget forecasting, planning and tracking for QA.
  • Establish and maintain quality metrics and reporting.
  • Coordinate, develop, maintain and/or provide GCP training to personnel.
  • Maintain relevant knowledge of both local and international auditing and appropriate GxP requirements and developments as they impact AGENUS’s SOPs and compliance with GxP, and communicate these to the QA team and QA management, as applicable.
  • Be familiar with GLP/GcLP required computer system validation requirements.
  • Maintain and / or develop records / documents for assigned areas.
  • May serve as a member of industry association boards, task forces, and committees and / or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic, or other similar groups influential in his / her area of expertise.
  • Develop and maintain network contacts with other quality assurance professionals.
  • Travel on assignment.
  • Participate in company preparations for regulatory inspections.
  • Manage GCP QA personnel to ensure that GCP systems are being appropriately monitored and executed.
  • Other assignments as directed by the Quality Assurance management team.

Qualifications

Knowledge And Experience

  • Extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing.
  • At least 8 years’ experience in GCP Quality Systems that support pharmaceutical development.
  • A minimum of five years’ experience in a staff leadership role, demonstrating strong leadership skills of staff and peers.
  • Expertise in GCP regulations and guidance for FDA and International agencies including ICH guidelines.

Education

  • Educated to degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.
  • Master’s degree in a science, technology or industry related discipline, preferred.

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