Director, Global Validation

15+ years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/21/17
San Diego, CA
15+ years experience
Salary depends on experience
Posted on 09/21/17

Leadership Responsibilities:

  • Connects people to a higher purpose and motivatesothers to action based upon personal integrity and professional credibility
    • Leads cross-functional teams by guiding execution decisions based on company strategy in a compelling and motivating manner
    • Establishes context of validation goals to support company vision and meet customer needs
    • Communicates strategy within department
    • Establishes credibility and effectively influences executives and peers across organizations
    • System-level expert able to integrate across multiple disciplines and work streams
    • Expert in leading resolution of multi-disciplinary, cross-departmental quality problems
    • Identifies new capabilities, processes and initiatives
    • Monitors evaluations, providing input on final decisions
  • Executes and achieves results forinternal and external customers in an efficient and effectively
    • Executes to achieve results of multiple functions across validation entities.
    • Provides direction to subordinate managers
    • Participates in setting validation department strategies. Sets functional strategy with 2 year time horizon
    • Plans at the department level to meet strategic needs, with a cross-departmental perspective. Manages department budgets & resource allocation
    • Prioritizes, aligns and balances utilization of multiple functional teams based on department priorities
    • Provides direction on resource questions that are escalated
  • Grows and develops a high performing validation team that can readily adapt and meet the changing needs of the organization
    • Mentors managers within the department, and provides coaching to leaders within project teams from other departments
    • Translates department strategies into cross-functional staffing plans. Hires in alignment with current and future needs, and creates new roles to meet future department needs
    • Defines and implements process and structure changes necessary to scale the department by understanding future needs based on department strategy and company direction
  • Collaborates and works withothers (up, down and across the organization) in a way that brings the best thinking forward
    • Proactively builds and maintains positive relationships department executives, company leaders, and key external stakeholders
    • Collaborates effectively across departments and sites, creating an environment of mutual trust
    • Works effectively with outside partners where appropriate, managing external partnerships
    • Establishes frameworks for collaboration and drives ongoing relationship, ensuring alignment with technology roadmap and project needs
    • Ensures regular evaluation of partner agreements and initiates changes as needed, interacting at least monthly with partner organizations.


  • Managing risk to ensure process capabilities and control for all products manufactured at a site, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle.
  • Ability to implement and maintain a comprehensive validation and process control program using operational excellence.
  • Overseeing QA aspects of Site Master Validation Plans, objectively maintaining manufacturing operations in a ‘validated state’
  • Support cross-functional root cause analysis and problem solving on escalated technical product / process issues (e.g., recurring deviations, quality-investigations, CAPA-studies)
  • Ensure development and deployment of highly specialized skills appropriate to the Validation team to meet the needs of the site's product portfolio and strategy
  • Fostering of knowledge development and transfer among the Validation team
  • Working with other regional Site Validation teams, or Business Units, driving reapplication of standard work processes, reapplication of best practices specifically in validation, training, process changes and handling of discrepancy and investigation resolution
  • Demonstrate compliance of validated manufacturing processes to governing bodies (FDA/NBs) during quality audits and regulatory inspections (e.g. PMIs)
  • Corresponding to post market activities (complaint handling / failure investigations) relating to manufacturing of products
  • Excellent written and oral communication skills
  • Comprehend manufacturing validation strategies and reports
  • Detail oriented, self-motivated, strong leadership skills with demonstrated ability to guide and influence large teams effectively
  • Occasional travel may be required

Preferred Skills:

  • Six Sigma or equivalent credentials in operational excellence
  • Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CSQE, CQA, RAC), through ASQ or AAMI

Education / Experience:

  • Bachelor’s degree in an engineering, chemistry or scientific discipline
  • Graduate degree in an engineering or scientific discipline and/or business strongly preferred;
  • 15+ years of experience in manufacturing / manufacturing science and technology / technical development / quality in medical devices/IVD industry, with 5 years of managing staff.
  • Thorough understanding of manufacturing processes and IVD (reagents) related process equipment
  • Strong working knowledge of appliedstatistics, quality systems (ISO13485) and regulatory (IVDD/21CFR820) requirements across multiple health authorities (AMERICAS/EUROPE/ASIA PACIFIC). 5 years of experience in executing process validation, having led and managed validation projects


Not the right job?
Join Ladders to find it.
With a free Ladders account, you can find the best jobs for you and be found by over 20,0000 recruiters.