Senior Quality Assurance Manager

2 weeks ago

King of Prussia, Pennsylvania, United States Exelixis Full time

Job Summary:

Exelixis is seeking a highly skilled Senior Quality Assurance Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for assisting in the development, implementation, and maintenance of quality systems and activities supporting Good Clinical Practice (GCP) and Pharmacovigilance (PV) operations.

Key Responsibilities:

  • Assist in the development of internal processes and systems related to GCP and PV quality activities.
  • Provide direct support to clinical study teams and participate in quality planning and implementation to support study operations.
  • Participate in the development and approval of the quality audit schedule, including the contracting of PV and GCP audits to contractors and conducting complex audits.
  • Develop, track, and manage periodic management reports, including key clinical and PV compliance and quality metrics.
  • Participate in and support various development teams.
  • Manage and/or participate in complex audits and regulatory inspections.
  • Independently determine approaches to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented.
  • Support, train staff, and oversee GCP/PV consultants.
  • Implement policies and/or procedures within quality assurance.
  • Partner with other groups, including Regulatory Affairs, Clinical Operations, and Translational Medicine, regarding compliance issues and provide compliance guidance to all audited parties.
  • Maintain knowledge of current regulation requirements and inform Clinical Development stakeholders of potential impact on the organization.
  • Provide support during external audits and regulatory authority inspections.
  • Participate in the development and delivery of GCP training internally.
  • Represent quality assurance in internal presentations on quality issues, initiatives, and projects.

Requirements:

  • BS/BA degree in a related discipline and a minimum of nine years of related experience, or
  • MS/MA degree in a related discipline and a minimum of seven years of related experience, or
  • PhD in a related discipline and a minimum of two years of related experience, or
  • Equivalent combination of education and experience.

Preferred Qualifications:

  • Typically requires a minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.
  • At least 6+ years of progressive related experience.
  • Experience in the biotech or pharmaceutical industry is preferred.

Knowledge/Skills:

  • Demonstrated knowledge of the drug development process.
  • Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines.
  • Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV quality, for global regulatory filings.
  • Excellent verbal and written communication skills.
  • Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
  • Develops technical solutions to complex problems.
  • Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
  • Guides the successful completion of major programs, projects, and/or functions.
  • Interprets, executes, and recommends modifications to company-wide policies and/or divisional programs.
  • Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Detailed-oriented and committed to precision in execution of tasks and processes.
  • Has knowledge of other related disciplines.
  • Must be proficient in Word, Excel, PowerPoint, and Visio.

Job Complexity:

  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
  • Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure).
  • Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes and corporate goals.
  • Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
  • Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
  • Work with various CROs and team members to ensure Exelixis project/program goals are met.

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