Senior CSFM Lead

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

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Job Purpose:

The Senior CSFM Lead is an experienced CSFM Lead and responsible for maintaining oversight of the Clinical and Safety Finding Management process, verifying that the Quality Strategy is being executed and reviewing and approving process outputs at key points in the process. They maintain and update the 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 Senior CSFM Lead is also responsible for performing trending analysis of the quality events data to identify patterns and potential systemic findings and coordinating review with the Global Process Quality Responsible and Global Process Owner.

 Primary Responsibilities and Accountabilities:

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

  • Reviews and confirms the criticality of findings to ensure global consistency of assessment
  • Leads Root Cause Analysis and coordinates the development of a CAPA plan for the CSFM process or in the absence of an appropriate Quality Responsible
  • Oversight
    • Contributes to and is responsible for relevant parts of the Quality Strategy of the CSFM process
    • Monitors performance indicators, operational metrics and data accuracy in the quality events system and drives appropriate actions based on the outcome
    • Reviews content of CSFM documentation and tools and proposes improvements to procedures, processes or systems changes to enhance the CSFM process including oversight and global tracking
    • Supports the development of annual goals and objectives supporting CSFM strategy
    • Identifies issues requiring escalation and supports the escalation to the relevant governance bodies
  • Reviews possible systemic issues with GPQR and GPO and ensures appropriate action is taken
  • Establishes partnership / relationship with relevant stakeholders and leads interactions with assigned stakeholders
  • Supports Inspection Management Team in preparation for and conduct of regulatory authority inspections and acts as CSFM SME
  • Strong in most QA Professional capabilities
  • Mentors CSFM personnel 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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