Senior CSFM Lead

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

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Job Purpose:

The PDQ Quality Lead supports the Roche/Genentech Organization through the design and delivery of Quality Assurance strategies for Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Computer Systems (CS). Quality Assurance strategies will have defined quality measures (impact factors) and objectives based on business surveillance and the use of data analytics at a Molecule/Process and Affiliate level. The Quality Lead will generate Quality Assurance strategies, evidence and actionable data through the conduct of activities (including audits) to assess the Quality status and be able to demonstrate effective implementation of Quality Assurance to stakeholders and Health Authorities. The Senior Quality Lead is an experienced Quality Professional who will be able to lead the delivery of Quality strategies across multiple GxP or CS areas. In addition, the Senior Quality Lead will lead the delivery of PDQ work, development of PDQ processes and procedures, participate in PDQ goals and initiatives, and lead regulatory authority inspections.

Primary Responsibilities and Accountabilities:

Design and Implementation of Quality Assurance strategies

  • Establish strong partnership/relationship with business stakeholders
  • Define molecule/process/affiliate level approach with appropriate measures (impact factors) to enable oversight and management of Quality
  • Assess specific risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the Quality Assurance strategy where necessary
  • Define the activities that need to be conducted to deliver the Quality Assurance strategy and provide evidence of effective implementation
  • Lead the development of methodology including the use of data analytics and maintain related tools/procedures.

Delivery of activities to assess Quality Assurance status

  • Independently perform and lead Quality activities including preparation, conduct, presentation and timely reporting of outcomes, and evaluation of actions taken
  • Group individual issues into systematic issues and areas of opportunity for process improvement beyond the individual findings
  • Present observations and associated compliance risks to business stakeholders and Pharma representatives and prepare a written report where required. This should require minimal input from manager/report reviewer
  • Ensure appropriate action plans have been developed and determine acceptability of evidence of compliance per the Clinical and Safety Finding Management (CSFM) process
  • Lead discussions to discuss unresolved issues with Senior Management
  • Mange ‘for cause’, critical, and/or complex quality issues
  • Escalate significant issues to PDQ management

Demonstration of implementation of Quality Assurance strategy to Health Authorities

  • Lead or support inspection preparation and management of Health Authority inspections. Activities including but not limited to: provide inspection training to staff, prepare, review and provide relevant inspection materials on request and presentation of Quality strategies and associated documentation during Inspections

Contribute to the development and execution of PDQ goals and initiatives

  • Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
  • Lead the development and/or revision of PDQ processes and procedures including SOPs, Work Instructions, and risk assessment tools
  • Provide education and/or training to business stakeholders as required
  • Act as trainer and mentor for junior staff providing meaningful feedback on a person’s performance in close collaboration with their line manager
  • Perform other tasks as assigned by line management

Maintains highest level of awareness and expertise in GxP regulations and internal policies and SOPs

  • Assess impact of new regulations and guidance on GxP activities
  • Maintain in-depth knowledge of company policies, SOPs, and supporting documents related to drug development as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations that may affect drug development and postmarketing processes (as applicable)

Professional and Technical Requirements

Education/Qualifications:

  • Masters, 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 7 years in pharmaceutical industry and/or quality assurance
  • Minimum 5 years in GCP/PV/CS/GLP related discipline
  • Demonstrated applied knowledge of clinical / pharmacovigilance / drug safety and regulatory requirements, as well as analytical, organizational and planning skills
  • Project management experience with proven leadership, mentoring and coaching

Desired:

In addition to having proficiency in the conduct of GxP audits, an ideal candidate will also have:

  • Experience supporting regulatory authority inspections
  • Ability to formulate clear business questions that can be answered with data
  • Proficiency in utilizing data and visualisation tools to generate insights

Reports to: Team Lead/Strategy Head

Experience, Skills, Knowledge:

  • Experience, competency, and proven track record developing audit and quality oversight strategies in GXP areas
  • In-depth knowledge of drug development processes and GXP regulations
  • Ability to influence and negotiate effective solutions within PDQ 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
  • Demonstrated strong analytical, problem-solving, and decision-making 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

Level: Senior

Highly Weighted Competencies:

  • Leading teams and acting globally
  • Collaboration and teamwork
  • Managing projects
  • Communicating and presenting
  • Critical Thinking
  • Self-Assurance
  • Data Analytics

Other

  • Travel: up to 30%

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