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    Associate Director Sr. Director, Quality Assurance - San Diego, United States - Regulus Therapeutics

    Regulus Therapeutics
    Regulus Therapeutics San Diego, United States

    4 weeks ago

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    Description

    Associate Director Sr. Director, Quality Assurance

    Position Description and Scope:

    We are seeking a candidate to lead our Quality Assurance activities, contributing valuable expertise and skills to the management of the Companys development programs. They will oversee all Quality Assurance duties, managing the quality of Regulus developmental and clinical studies both domestically and internationally. This position requires hands-on Quality Management, creating, reviewing, and maintaining documents for GXP practices, conducting vendor audits and reviews, and managing outside quality vendors where appropriate. Additionally, they will be responsible for maintaining and enhancing processes and methods to ensure the quality of studies conducted by both Regulus and our contracted service providers.

    Job responsibilities:

    Oversee and lead the Quality Assurance department, providing strategic direction and guidance to ensure compliance with regulatory requirements and industry standards.

    Develop and implement quality assurance policies, procedures, and systems to support the company's goals and objectives.

    Direct the planning, execution, and review of quality audits and inspections to assess compliance with GMP, GLP, and GCP regulations and manage vendor qualification.

    Assist in the development and implementation of GXP-compliant systems.

    Conduct technical reviews of validation activities for GLP analytical and bioanalytical groups.

    Aid in the establishment and adherence to vendor Quality Agreements.

    Perform quality review of GXP study protocols and reports. Collaborate with cross-functional teams to ensure quality standards are maintained throughout all stages of product development, manufacturing, and distribution.

    Lead investigations into deviations, non-conformances, and complaints, implementing corrective and preventive actions as necessary to mitigate risks and improve processes.

    Manage inspections by regulatory agencies and assist with responses to findings.

    Stay current with industry trends, regulatory changes, and best practices to drive innovation and enhance quality systems.

    Minimum Qualifications:

    Bachelor's degree in a relevant scientific discipline or equivalent experience.

    At least 10 years of progressive experience in quality assurance roles within the pharmaceutical, biotechnology, or related industry.

    In-depth knowledge of global regulatory requirements, including FDA and ICH cGMP/GLP guidelines.

    Experience leading quality assurance initiatives and managing quality initiatives with GXP vendors.

    Strong analytical skills and problem-solving abilities, with a keen attention to detail.

    Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

    Strong ability to multitask, as the position requires executing multiple projects simultaneously.

    Excellent written and oral communication skills, including report writing.

    Strong computer skills (Excel, Word, PowerPoint, Project).

    Some travel to CMOs and vendors to audit and oversee cGMP/GLP compliance is required.

    Preferred Qualifications:

    Advanced degree (e.g., Master's or Ph.D.) in a relevant scientific discipline.

    Experience in the development and implementation of quality metrics and key performance indicators (KPIs).

    Benefits:

    The expected hiring range for this multi-level position is $180,000-$210,000 per year, commensurate with educational level and experience.

    Generous annual bonus program and company stock options

    Access to a 401k plan with generous employer match.

    Full suite of health plans including medical plan options, dental, vision, life insurance, disability, EAP, and more.

    Access to Flexible Spending Accounts.

    Generous vacation, paid holiday, and sick leave policies.

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