Director/Sr. Director, Quality Operations

hace 1 mes

Caimito, Puerto Rico Jobleads-Us A tiempo completo

Director/Sr. Director, Quality OperationsAlameda, CA
Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design platform for CRISPR-based genetic medicine.
We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Director / Senior Director, Quality Operations to join our team and advance our platform. The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building Quality Operations and Compliance strategies for CRISPR-based therapeutics. Furthermore, the candidate would offer expertise in efficiently navigating the GXP complexities inherent to gene editing programs.
Key Responsibilities: Lead our growing quality functionsBuild and lead a strong QMS, ensuring compliance with regulatory requirements, maintaining audit readiness and interfacing with CDMO/CRO quality and technical teams, and driving continuous improvement initiatives across all aspects of our operationsDevelop and implement quality management systems (QMS) in accordance with applicable regulations (e.g., FDA, EMA, ICH) and industry best practicesOversee all quality control and quality assurance activities throughout the product or project lifecycle, including supplier qualification and raw material testing, in-process monitoring, and final product releaseCollaborate with stakeholders on quality and compliance aspects of technology transfer and new product introductionServe as an expert resource for GXP training activitiesEstablish and maintain key performance indicators (KPIs) to track and improve quality metrics for management reviewDevelop and maintain process(es) for product life cycle management from Research to Development and into ClinicStay abreast of emerging regulations, guidance, standards, and industry trends relevant to cell and gene therapy productsConduct internal audits and provide support towards interactions with Regulatory agencies, ensuring adherence to GXPCollaborate with cross-functional teams to address compliance issues, CAPAs, and quality system deficienciesChampion a culture of compliance and quality excellence through training, coaching, and fostering a mindset of continuous improvementLead risk assessment activities to identify and mitigate quality and regulatory risksDevelop risk management plans and ensure proactive risk mitigation strategies are implementedRecruit, mentor, and develop a high-performing team of quality professionalsProvide strategic direction and leadership to the quality teamAssist in developing and supporting an operating budgetCollaborate cross-functionally on regulatory submissionsProvide Quality review and impact assessment of proposed Change Control recordsRequired Skills and Background: Minimum 10 years experience in quality assurance, quality control, and/or quality operations within the biotechnology industryIn-depth knowledge of global regulations governing cell and gene therapy productsStrategic thinker with a demonstrated ability to develop and implement quality and regulatory strategiesAttention to detail and ability to lay out Quality Operations into systems processes and proceduresExperience writing SOPs, reviewing protocols and reports, and maintaining a document control systemExperience with QMS and ability to onboard, implement and maintain a validated QMSExceptional communication skills to mentor and train in compliance mattersExperience with regulatory inspections and/or CDMO/CRO auditsStrong collaboration skills with a congenial attitudeAbility to manage complex schedules and shifting priorities in a dynamic environmentSalary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.

#J-18808-Ljbffr

  • Restaurant Director

    hace 3 semanas

    Caimito Barrio, Puerto Rico Domino'S Pizza Llc A tiempo completo

    Job Summary: As a key member of our team, the Restaurant Director will oversee the daily operations of our Domino'S Pizza Llc location. This includes managing staff, maintaining high-quality customer service, and ensuring efficient food preparation and delivery. Main Responsibilities:Manage and coordinate staff to ensure smooth day-to-day operationsMonitor...

  • Assistant Director/Administrator

    hace 1 mes

    Caimito, Puerto Rico Aec Living A tiempo completo

    Job Summary:The Assistant Administrator (or Assistant Director) is a full-time salaried position located in Alameda, California. This individual will support the Administrator/Director with day-to-day operations, managing staff, and providing exceptional customer service. The ideal candidate will have previous experience in either health care or hospitality...

  • Athletic Director

    hace 1 mes

    Caimito, Puerto Rico Roman Catholic Welfare Corporation Of Oakland, St.Joseph Not A tiempo completo

    We are currently seeking a full-time Athletic Director for approximately three months. The Athletic Director provides professional assistance to the Principal in leading and ensuring the quality of all interscholastic athletic programs for Saint Joseph Notre Dame High School in order to achieve the fullest attainment of the school's unique Catholic mission. ...

  • Clinical Operations Director

    hace 3 semanas

    Caimito Barrio, Puerto Rico Iuvo Bioscience A tiempo completo

    Job Title: Associate Director Clinical OperationsCompany: Iuvo BioscienceJob Description:Key Responsibilities:Provide strategic direction to study teams to meet corporate study goals and timelines.Oversight of vendor budgets and contracts, in conjunction with Development Outsourcing reporting and justification of study metrics to executive management, as...

  • Director, Client Relationship

    hace 1 mes

    Caimito, Puerto Rico Jobleads-Us A tiempo completo

    Title: Director, Client RelationshipDepartment: Client ServicesBargaining Unit: NBU Grade: N/APosition Type: Exempt Hours per Week: 40Position Summary The Director, Client Relationship directly leads a defined book of business (BOB), comprising a set of named clients, in accordance with Company guidelines, client needs, and regulatory requirements. The...

  • Director Of Nursing

    hace 1 mes

    Caimito, Puerto Rico Franciscan Ministries A tiempo completo

    Overview: St. Joseph Villageis looking for a Director of Nursing (DON)! The primary function of the Nursing Director is to plan, organize, develop and direct the overall operation of the nursing department in accordance with current applicable federal and state agency regulations and with current standards of gerontological nursing practice. If you have a...

  • Director of Quality Assurance Data Analytics

    hace 1 mes

    Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Job SummaryAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Nursing Department Director

    hace 2 semanas

    Caimito Barrio, Puerto Rico Franciscan Ministries A tiempo completo

    Job SummaryFranciscan Ministries is seeking a highly experienced and skilled Nursing Department Director to lead the Nursing Services department in our vibrant senior living community in Chicago, Illinois. The successful candidate will have a strong background in nursing management and a passion for providing high-quality care to our residents.Main...

  • Nursing Department Director

    hace 3 semanas

    Caimito Barrio, Puerto Rico Franciscan Ministries A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced Nursing Department Director to lead our nursing team at St. Joseph Village of Chicago, a proud part of Franciscan Ministries. As a Director of Nursing, you will be responsible for planning, organizing, developing, and directing the overall operations of the Nursing Department in accordance with...

  • Activity Director

    hace 3 meses

    Caimito, Puerto Rico Oakmont Senior Living A tiempo completo

    Position: Activity DirectorShifts, Time, and Days: Tuesday- Saturday 9 am-5:30 pmPay Range: $27-$30Oakmont of Mariner Point is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group, we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a rewarding...

  • Associate Director, Project Leadership

    hace 2 meses

    Caimito, Puerto Rico Abbott Laboratories Company A tiempo completo

    Define, plan, coordinate and integrate activities associated with existing products updates or geographic expansion commercialization within the overall business portfolio on time, on budget and on strategy. These activities include coordination of a Project Lead, Leadership, Director, Associate, Leader, Project Management, Healthcare, Business Services

  • Store Operations Manager

    hace 2 semanas

    Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completo

    Role SummaryAs a Store Operations Manager at Jobleads-Us, you will play a critical role in driving the success of our retail business. This role serves as a developmental position towards becoming a Store Director, achieving readiness within 12 months. We are seeking a passionate and results-driven individual to join our team. About the RoleThe successful...

  • Bioanalysis Director

    hace 4 semanas

    Caimito Barrio, Puerto Rico Exelixis A tiempo completo

    Job SummaryThe Bioanalysis Director will oversee GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. This role will manage CRO-outsourced bioanalysis for small molecules and biologics, as well as provide project management support for external and internal...

  • Regulatory Affairs Director

    hace 2 semanas

    Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completo

    About the RoleJobleads-Us is seeking an experienced Regulatory Affairs Director to join our team in the APAC region. As a key member of our Regulatory Operations team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to mitigate risks.Key ResponsibilitiesDevelop and implement regulatory strategies to...

  • Data Analytics Director

    hace 2 semanas

    Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completo

    About AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Plant Maintenance Director

    hace 3 semanas

    Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completo

    **Key Responsibilities:**As a Plant Maintenance Director, you will be responsible for ensuring a safe and comfortable environment for residents, staff, and visitors. This includes performing preventative maintenance procedures, maintaining equipment, and understanding department budgets.**Qualifications:**To be successful in this role, you will need one year...

  • Director Clinical Pharmacology And Pharmacometrics

    hace 1 mes

    Caimito, Puerto Rico Epm Scientific A tiempo completo

    Company Overview: Join a leading biotechnology company dedicated to the discovery and development of innovative therapies for cancer and other serious diseases. We are seeking a highly motivated Director of Clinical Pharmacology and Pharmacometrics to help advance our portfolio of small molecules and biologics through all stages of drug development. This...

  • Senior Project Director

    hace 2 semanas

    Caimito Barrio, Puerto Rico Gpac A tiempo completo

    About the RoleThe Senior Project Director will utilize judgment and discretion in representing GPAC, while showcasing a high level of commitment and involvement with their work and the company's business. This position requires a strategic, talented, and enthusiastic individual to foster and promote our company culture through their personal positive...

  • Hvac Project Director

    hace 1 mes

    Caimito Barrio, Puerto Rico Gpac A tiempo completo

    Job SummaryGPAC is seeking a highly skilled Hvac Project Director to lead our team in delivering exceptional results. The ideal candidate will have a strong background in HVAC project management, excellent communication skills, and the ability to work effectively in a fast-paced environment.Key Responsibilities Develop and maintain strong relationships with...

  • Maintenance Director For Senior Living

    hace 1 mes

    Caimito, Puerto Rico Jobleads-Us A tiempo completo

    Oakmont of Mariner Point is a premier senior living community situated on a beautifully landscaped campus. Managed by Oakmont Management Group, we provide exceptional quality, comfort, and care with five-star services and amenities. Residents enjoy a rewarding lifestyle with individualized comprehensive support that promotes continuing independence. We...