Lead GCP Quality Assurance Manager

2 weeks ago

King of Prussia, Pennsylvania, United States EXELIXIS Full time
JOB SUMMARY:
Accountable for enhancing, implementing, and maintaining quality assurance systems and operations that support Good Clinical Practice (GCP) and Pharmacovigilance (PV) activities. Provides assistance in the planning and execution of vendor audits and related documentation tasks.

Key Responsibilities:
  • Assist in the formulation of internal processes and systems pertinent to GCP and PV quality assurance activities;
  • Offer direct support to clinical study teams, engaging in quality assurance planning and execution to facilitate operational efficiency;
  • Participate in the creation and endorsement of the Clinical Quality Assurance (CQA) audit schedule, which includes contracting for PV and GCP audits and conducting detailed audits;
  • Develop, track, and oversee management reports that encompass essential Clinical and PV Compliance and Quality Assurance metrics;
  • Support various development teams as needed;
  • Manage and engage in complex audits and regulatory inspections;
  • Independently address intricate compliance challenges, report findings to management, and propose solutions;
  • Provide training to staff and oversee GCP/PV consultants;
  • Uphold policies and procedures within Clinical Quality Assurance;
  • Collaborate with other departments on compliance issues and provide guidance to all parties involved in audits;
  • Stay updated on current regulatory requirements and inform Clinical Development stakeholders of potential impacts on the organization;
  • Assist during external audits and inspections by regulatory authorities;
  • Contribute to the design and delivery of internal GCP training programs;
  • Represent Clinical Quality Assurance in internal presentations focusing on quality matters, initiatives, and projects.
Supervisory Responsibilities:
  • None
Qualifications:
  • BS/BA degree in a relevant field with a minimum of nine years of pertinent experience; or,
  • MS/MA degree in a relevant field with a minimum of seven years of pertinent experience; or,
  • PhD in a relevant field with a minimum of two years of pertinent experience; or,
  • Equivalent combination of education and experience.
Experience:
  • Typically requires a minimum of six to eight (6-8) years of related Clinical Quality Assurance, GCP, and PV experience, and/or a combination of experience and education/training.
  • At least 6+ years of progressive related experience.
  • Experience in the biotechnology or pharmaceutical sector is preferred.
Knowledge and Skills:
  • Demonstrated understanding of the drug development lifecycle.
  • Proven experience in conducting and managing audits, particularly in GCP and PV areas;
  • Familiarity with preparation and submission activities, especially concerning GCP and PV Quality for global regulatory filings.
  • Strong communication abilities.
  • Capability to influence and negotiate effectively within a team; excellent interpersonal skills.
  • Expertise in problem-solving.
  • Ability to implement innovative solutions to complex challenges;
  • Detail-oriented and committed to precision in task execution.
  • Proficient in Microsoft Word, Excel, PowerPoint, and Visio.
Job Complexity:
  • Addresses significant and unique challenges requiring evaluation of intangibles;
  • Capable of multitasking and managing complex assignments;
  • Handles complex issues necessitating in-depth knowledge of clinical research and PV processes;
  • Utilizes independent judgment in decision-making to achieve results;
  • Contributes to the development of methods and criteria for projects and programs;
  • Collaborates with various teams to ensure project objectives are met.

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