Principle CSFM Lead

United States of America, California, South San Francisco
Switzerland, Basel-City, Basel
Canada, Ontario, Mississauga
United Kingdom, Welwyn

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Job Purpose:

The Principal CSFM Lead is a highly experienced CSFM Lead and responsible for maintaining oversight of the Clinical and Safety Finding Management process, coordinating the development and maintenance of the Quality Strategy is being executed and reviewing and approving process outputs at key points in the process. They oversee the maintenance and update of tools, templates and training that support the end-to-end process and support the Head of CSFM in providing data and performance metrics to stakeholders and Senior Management. The Principal CSFM Lead is also responsible for performing trending analysis of the quality events data and trending across processes to identify patterns and potential systemic findings for discussion with GPQRs, GPO and governance bodies.

Primary Responsibilities and Accountabilities:

In addition to the responsibilities of the Senior CSFM Lead (see separate job description), the Principal CSFM Lead:

  • Reviews criticality, draft finding responses and evidence of implementation for complex findings
  • Leads RCA and coordinates the development of a CAPA plan in complex scenarios for the CSFM process or in the absence of an appropriate Quality Responsible
  • Oversees:
    • Coordinates the maintenance and development of the Quality Strategy of the CSFM process
    • Develops and ensures oversight of performance indicators, operational metrics and data accuracy in the quality events system and drives appropriate actions based on the outcome
    • Develops and maintains dashboards and tools to ensure visibility of CSFM status to management
    • Reviews content of CSFM documentation and tools and proposes / approves improvements to procedures, processes or systems changes to enhance the CSFM process including oversight and global tracking
    • Develops and leads annual goals and objectives supporting CSFM strategy
    • Coordinates escalation process and leads the escalation to the relevant governance bodies
  • Reviews trends across processes and leads review with senior management
  • Leadership:
    • Influences stakeholders in relation to topics related to the CSFM process
    • Establishes partnership / relationship with relevant stakeholders and coordinates support assignments for stakeholders.
  • Supports Inspection Management Team in preparation for and conduct of regulatory authority inspections by leading the preparation and management for CSFM, including as inspection interviewee.
  • Strong in all QA Professional capabilities
  • Leads PDQ goals and initiatives as required
  • Maintains awareness of new regulations and guidance and assess the impact on GCP/GVP activities
  • Team:
    • Mentors CSFM personnel as required and supports the training and development of CSFM Leads
    • Supports the assignment of tasks to CSFM Leads and deputizes for Head of CSFM as required

Professional and Technical Requirements

Education/Qualifications:

  • Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
  • Advanced degree in referenced fields preferred

Minimum:

  • Minimum 10 years in pharmaceutical industry and/or quality assurance
  • Minimum 7 years in GxP related discipline
  • Demonstrated applied knowledge of GCP and/or pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills
  • Project management experience
  • Leadership, mentoring and coaching experience

Desired:

  • Experience line managing, developing staff and leading teams
  • Experience supporting regulatory authority inspections

Experience, Skills, Knowledge:

  • Experience, competency, and proven track record developing strategies in CAPA Management
  • Strong understanding of QMS
  • In-depth knowledge of drug development processes and GCP/PV regulations
  • Ability to influence and negotiate effective solutions within a function and with business stakeholders
  • Ability to work in an international multicultural matrix organization
  • Ability to assimilate new and emerging compliance information or trends
  • Demonstrated ability to work both independently and in a team environment
  • Ability to motivate team members
  • Demonstrated strong analytical, problem-solving, and decision-making skills and ability to manage complex situations
  • Demonstrated critical thinking skills
  • Strong verbal and written communication (including presentation) and customer management skills
  • Demonstrated ability to effectively organize and execute tasks
  • Demonstrated ability to operate with a high level of personal leadership
  • Computer proficiency
  • Fluency in written and spoken English required
  • Bi or multi-lingual skills desirable

High Performance Competencies

Highly Weighted Competencies:

  • Leading teams and acting globally
  • Collaboration and teamwork
  • Managing projects/programs
  • Communicating and presenting

Other (e.g. Travel):

  • Travel: up to 25%

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