Principal Quality Lead

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

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Job Purpose:

The Quality Lead supports the Roche/Genentech organization through the design and delivery of Quality Assurance strategies for GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GVP (Good Pharmacovigilance Practice) and CS (Computer System), 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 Principal Quality Lead is a highly experienced Quality Professional who will be able to lead the design of complex Quality strategies in multiple GxP/CS areas. In addition, the Principal Quality Lead will lead and directly influence the delivery of PDQ work, development of PDQ processes and procedures, participate in PDQ goals and initiatives, and management of regulatory authority inspections.

Primary Responsibilities and Accountabilities:

  • Design and Implementation of Quality Assurance strategies
  • Establish strong partnership/relationship with business stakeholders
  • Independently define molecule/process/affiliate level approach with appropriate measures (impact factors) to enable oversight and management of Quality
  • Independently assess specific risk areas on an ongoing basis, communicate to PDQ senior leadership and propose modifications to the Quality Assurance program 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
  • Independently group individual issues into systematic issues and areas of opportunity for process improvement beyond the individual findings
  • Lead the presentation of observations and associated compliance risks to business stakeholders and Pharma representatives and prepare a written report where required. Lead discussions with other Pharma personnel including Legal, Regulatory Affairs, Clinical Operations, gRED, etc. regarding compliance issues
  • 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 independently
  • Escalate significant issues to PDQ management

Demonstration of implementation of Quality Assurance strategy to Health Authorities

  • Lead 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

  • 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 (in a broad range of audit disciplines) for International and Senior Quality Leads providing meaningful feedback on a person’s performance in close collaboration with their line manger
  • 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 expert knowledge of company policies, SOPs, and supporting documents related to drug development, post marketing and CS 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 post-marketing processes (as applicable)

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 nonclinical/clinical research/PV experience
  • Minimum 8 years in GCP/PV/CS/GLP related discipline / Quality Assurance role (auditing) 
  • 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, the ideal candidate also demonstrates:

  • 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

Dotted Line Reports: N/A

Experience, Skills, Knowledge:

  • High degree of experience, competency, and proven track record leading multiple complex audit types in multiple GxP/CSV areas
  • Expert knowledge of drug development processes and GxP/CS regulations
  • Proven ability to influence and negotiate effective solutions within PDQ, PD, and/or industry through leading change and driving for results
  • Proven record of working in an international multicultural matrix organization
  • Demonstrated ability to effectively organize and execute tasks
  • Demonstrated excellent analytical, strategic- thinking, and problem-solving skills with a proven ability to understand business impact
  • Proven ability to assimilate new and emerging compliance information or trends and translate into impact for PDQ
  • Excellent verbal and written communication and customer management skills
  • Demonstrated ability to work both independently and in a team environment
  • Consistently 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: Principal

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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Roche is an equal opportunity employer.

Research & Development, Research & Development > Drug Safety