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Head of Quality Assurance

Duties and Responsibilities:

  • • Oversee and manage all Quality Assurance functions
    • Ensure that GxP quality processes and competencies are in place to drive a culture of compliance and collaboration
    • Lead preparedness for and conduct of health authority inspections. Establish and maintain positive relationship with FDA and other regulatory authorities.
    • Lead the development of pharmaceutical quality systems – aligning policies, processes and procedures with internal and outsourced activities
    • Assure that manufacturing activities and product testing are appropriate, are conducted in compliance with company policies and procedures, and that documentation is accessible and ensures traceability/accountability
    • Ensure that Quality Agreements are complete, approved and updated at appropriate intervals
    • Support planning, scheduling and performing GxP audits/inspections (internal and external) to assure adherence to company SOPs and any applicable regulatory requirements
    • Oversee risk assessments to determine level of compliance risk. Lead implementation of appropriate risk mitigation strategies
    • Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations
    • Support development of company training programs for GxP-related procedures, practices and system requirements
    • Manage process improvements for quality information management systems
    • Remain current with quality management trends. Review and interpret new regulations, and ensure that Progenics’ quality systems evolve accordingly
    • Oversee hiring of staff as well as external consultants
    • Recruit, train and mentor staff
    • Perform other duties as required
  • •  Prepare and manage department operating plans and budgets

Qualifications Required:

  • Bachelor’s degree in biopharma or related field. Advanced degree in related area preferred
    • Must have a minimum of [15] years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5+ years leading a Quality function for both development and commercial activities
    • Experience overseeing product approval (NDA or BLA) essential; i.e., transition from product development to commercial quality systems and operations
    • Experience establishing and/or enhancing development and commercial GxP quality infrastructure and systems compliant with U.S. and international requirements. Successful track record managing U.S. and international pre- and post-approval inspections
    • Extensive knowledge of GMP, GCP and GLP including 21 CFR Part 11
    • Proven track record in establishing and managing GMP/GCP Quality staff
    • Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation
    • Strategic thinker, able to integrate complex business considerations in formulating a quality approach
    • Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical, commercial and operations staff
    • Approximately 10% domestic and some international travel

 

 

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