Senior Manager, Quality Assurance-217325

Duties & Responsibilities:

• Plans, directs and manages the work of the BI Fremont Quality Assurance group; establishes department mission statements; and provides technical leadership to ensure all necessary quality checks are completed on time, and according to SOPs.
• Identifies deviations from SOPs in manufacturing operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolved.
• Provides oversight for the development of project budgets and monitors expenditures.
• Optimizes allocated department resources.
• Prepares for, manages and coordinates internal and customer audits including:
  • Coordination with internal contacts/customers on audit agenda
  • Completion of any internal/customer pre-audit requirements (questionnaires, etc.)
  • Coordination with internal departments on audit schedule
  • Coordination with internal departments and/or customer on responses to any observations
  • Overseeing tracking of CAPAs related to audits to monitor for timely completion

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    Requirements:

     

    • Requires a Bachelor's, Master's or PhD degree, from an accredited institution, preferably in Life Sciences Engineering or similar pursuit.
    • Requires a minimum of seven (7) years of experience working in the Quality aspects of a life sciences or closely related industry.
    • Requires a minimum of three (3) years of management and/or leadership experience, including experience managing within complex matrix organizations and projects.
    • Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
    • Negotiating skills
    • Overall understanding of Quality Assurance specifications and process
    • Budgeting
    • Goal setting
    • In-depth understanding of Manufacturing/Pharma Business
    • Strong team leadership skills
    • Strong staff coaching and development skills
    • Strong ability to communicate in an open, customer-focused manner
    • Strong ability to influence in a team environment and collaborate with peers.
    • Strong understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating
    • Strong team leadership skills
    • Strong ability to set vision and direction, set expectations and motivate
    • Strategic thinking and planning.
    • Performance focused, persistent, sound decision-making, open minded, innovative/creative and results oriented.
    • Ability to interpret and relate Quality standards for implementation and review to functional areas.
    • In-depth knowledge of relevant Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing.
    • Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
    • Ability to effectively communicate both verbally and in writing to peers, management and other functions; superior interpersonal effectiveness, facilitation and organizational skills.
    • High level of personal motivation and initiative, and ability to work independently on projects.
    • Ability to adapt and be flexible with project changes as well as a continuously-improving work environment.
    • Ability and willingness to maintain accurate and factual hard-copy and electronic records.
    • Ability and willingness to work, participate effectively in and lead a team environment, including cross-functional teams.
    • Attention to detail, safety, quality and customer requirements.
    • Proficiency with MS Office products (specifically Word, Outlook, and Excel)

    • Eligibility Requirements:

       

      • Must be legally authorized to work in the United States without restriction.
      • Must be willing to take a drug test and post-offer physical (if required)
      • Must be 18 years of age or older