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Menlo Park

    Associate Director, Quality Systems - Menlo Park, United States - Corcept Therapeutics

    Corcept Therapeutics
    Corcept Therapeutics Menlo Park, United States

    2 weeks ago

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    Description


    This Corcept Quality Systems leader will have primary responsibility for prioritizing and managing Quality Assurance (QA) and GxP computer systems projects.

    These responsibilities include daily technical operations, strategy development, project management, and resourcing. Projects include software enhancements and maintenance, new implementations, and other continual process improvements for Corcept.

    This is a hands-on role requiring technical expertise (system development lifecycle and computer system validation) software and technical project management talent, and proven leadership competence.


    The role will support all Corcept's quality and GxP operations and require collaboration with stakeholders across all levels of seniority.

    This will require the ability to recognize business improvement opportunities, evaluate urgency and diligently prioritize the project queue. Candidates should possess effective meeting facilitation skills, proficiency in project prioritization, and stakeholder expectation management.

    Because QA supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.


    Responsibilities:
    Prioritize and manage software projects including overseeing daily technical operations.

    Achieve quality and GxP objectives while effectively balancing competing priorities and potential compliance risks with ongoing projects.

    Support cross functional partnerships by delivering phase appropriate solutions for Corcept's quality management system.

    Recognize and assess opportunities that promote QA's ability to deliver innovative solutions that support Corcept's growth and evolving business needs

    Work with SMEs to develop controls and set management standards for system environments, while managing vendor relationships and licenses in line with Corcept's growth

    Support Inspection Readiness objectives by identifying risks and implementing fixes or developing risk strategies

    Mentor the Quality Systems team with development opportunities and ensuring the team's capabilities meet Corcept's future needs

    Implement improvements to GXP Standard Operation Procedures (SOPs)

    Support regulatory authority inspections, including by coordinating cross-functional partners, in inspection preparation, hosting and responding to observations.

    Preferred Skills, Qualifications and

    Technical Proficiencies:
    Experienced and well versed in System Development Lifecycle (SDLC)

    Working knowledge of Veeva Quality Suite, LMS systems

    Hands on configuration experience

    Direct involvement and experience with regulatory inspections and audits

    Large system implementations leading cross-functional groups

    Acumen and comfort in persuading and influencing others at various levels of the organization

    Vendor evaluation and selection process.

    Knowledge of principles for software validation and GAMP 5

    Excellent meeting facilitation and skills

    Excellent written and oral communication skills


    Preferred Education and Experience:
    BA/BS in a scientific discipline

    Strong knowledge of GCP and GMP requirements including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.)

    10 years' experience in pharmaceutical QA, including in a hands-on system role

    Experience in working with enterprise systems


    The pay range that the Company reasonably expects to pay for this headquarters-based position is $183,000 - $215,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

    Applicants must be currently authorized to work in the United States on a full-time basis.

    If you are based in California, we encourage you to read this important information for California residents linked here.

    #J-18808-Ljbffr
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