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Associate Director/Director Quality Assurance

Snap Staffing

Associate Director/Director Quality Assurance

La Jolla, CA
Full Time
Paid
  • Responsibilities

    Associate Director/Director Quality Assurance (San Diego, CA)

    SNAPSHOT!

    The Associate Director/Director Quality Assurance will join the executive management team and assist in the development and implementation of strategies, business plan, budget, and works plans to achieve company’s vision and mission. The position will provide leadership for all Quality activities to drive product development programs and ensure the Company’s ongoing compliance with regulatory mandates. Assure the quality of products and processes, and ensure the highest integrity in regulatory and quality compliance. Will lead teams to strategize product development plans and advise department leaders of quality considerations in-light-of the Company’s goals and overseeing all aspects of quality systems. Must be a dynamic leader with outstanding communication, strategic and collaboration skills, and will provide adept supportive leadership.

     

    Immediate need for a Start-Up Biotech Firm, looking for an Associate Director/Director Quality Assurance in San Diego, CA who possess:

    • Experience in all phases of regulatory submissions and interactions, including post-approval experience; international experience also required, along with direct contact and negotiation experience with the FDA.
    • Rare disease experience a plus.
    • Experience in leading the Quality function for a biopharmaceutical company and familiarity with GxPs.
    • Experience with electronic filing and database management abilities.
    • Experience with documentation systems and with document review and auditing.
    • Excellent communication skills, team member that can work collaboratively with colleagues across all functions.
    • Excellent analytical, presentation, writing, and computer skills are required.
    • Comprehensive knowledge of current US and ex-US regulatory guidelines.
    • Demonstrate excellent leadership and communication skills.
    • Demonstrate strong organizational skills, including the ability to prioritize personal workload.
    • Extensive supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
    • Senior managerial experience in a small company environment is desirable.
    • Ability to work well in a deadline-driven environment.
    • Capable of supporting multiple projects simultaneously.

     

    Key responsibilities include:

    • Manages and directs QA personnel responsible for GMP oversight of API and drug products produced at contract manufacturing sites, as well as applicable GCP and GLP study sites. Includes resource planning, prioritization of resources and projects.
    • Directs a wide variety of activities to ensure compliance with quality systems, quality procedures, quality policies and applicable regulatory requirements to facilitate compliance with regulatory agencies and business requirements.
    • Develops and implements and maintains programs/processes to ensure high quality products and compliance with cGMP.
    • Responsibilities include the final release of commercial API and drug product for global markets.
    • Directs and mentors’ staff in complex technical complaints, investigations, regulatory agency correspondence and recall management.
    • Represents company as host of regulatory GMP inspections at applicable contract site and supports inspections at CMO facilities.
    • Works with Pharmaceutical Development and Manufacturing teams during technology transfer of new product start-ups, establishing key checkpoints for new products and processes, and managing change implementation.
    • Develops and implements a departmental budget that meets all corporate and quality assurance goals and requirements.
    • Directs compliance audits as required.
    • Reviews and approves regulatory submissions.
    • Interfaces with regulatory agencies as required representing the company to authorities and regulatory inspectorates.
    • Reviews, approves, and directs implementation of changes to controlled documents and processes (e.g., SOPs, Specifications, Methods, etc.) as needed.
    • Perform other duties as required
    • Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
    • Minimum of 15 years of experience in pharmaceutical / biotech
    • Minimum 10 years in a management role within Quality Assurance

    For immediate considerations please email your resume to admin@snapstaffing.com