Senior Operations Quality Assurance Manager

hace 1 semana


Caimito Barrio, Puerto Rico Exelixis A tiempo completo
Job Title: Senior Operations Quality Assurance Manager

Job Summary: We are seeking a highly skilled Senior Operations Quality Assurance Manager to join our team at Exelixis. This role is critical to the success of our clinical and commercial programs and requires continuous communication to maintain alignment across the organization.

Key Responsibilities:

  • Manage end-to-end quality standards defining the framework for GxP warehousing and transportation management systems.
  • Partner with QA and cross-functional teams to drive process improvements and ensure compliance with regulatory requirements.
  • Develop and implement quality metrics and tracking systems to monitor and improve performance.
  • Collaborate with 3PL network partners to maintain performance and continuous improvement.
  • Represent QA in strategic and decision forums, and triage communication between Exelixis business functions and QA.

Requirements:

  • Bachelor's degree in a related field and a minimum of 9 years of experience in biotech, pharmaceutical, or related industry.
  • Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems, and technical expertise in warehousing/storage and transportation/shipping processes and product quality decision-making.
  • Excellent written, verbal, and presentation communication skills, and ability to translate complex concepts across all levels of the organization.
  • Ability to lead through change and identify opportunities resulting in positive business outcomes.

What We Offer:

  • Competitive base salary range of $140,000 - $199,000 annually.
  • Comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • Discretionary annual bonus program and sales-based incentive plan for field sales staff.
  • Opportunity to purchase company stock and receive long-term incentives.


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