Manager, Quality Operations

2 weeks ago

Boston, United States Elektrofi Inc Full time
Job DescriptionJob DescriptionDescription:

ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of BiologicsTM.


POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as Manager, Quality Operations to support the development of the novel Elektrofi formulation platform. The individual will join a growing, multidisciplinary team of scientists/engineers and industry professionals.

Reporting to the Director of Technical Quality Assurance, the Manager, Quality Operations will play a pivotal role in ensuring the quality and compliance of Elektrofi programs from development through to commercialization. This position involves closely working with the Technical Development and Internal Manufacturing teams to implement and maintain quality engagement that aligns with both internal and external phase-appropriate requirements. This role has responsibility for quality oversight of suppliers and technology transfers to Contract Development/Manufacturing Organizations (CDMOs).


KEY RESPONSIBILITIES

  • Provide Quality support for internal and external manufacturing activities and performs batch disposition activities
  • Collaborate with internal and external business partners to conduct quality investigations /deviations and conduct reviews of CAPA plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
  • Develop and implement a structured vendor management process to ensure the selection, evaluation, and continuous monitoring of vendors, ensuring compliance with quality standards and enhancing collaboration
  • Manage quality oversight of the internal materials management process.
  • Support the authoring and review of Quality Agreements between CMOs/Suppliers and Elektrofi, as needed
  • Coordinate and review change control activities.
  • Coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
  • Conduct GMP document review, including procedures, work instructions, specifications, test methods, qualification/validation protocols, and reports.
  • Conduct review of Master and Executed Batch Records, in process, release and stability data and support product disposition
  • Identify compliance risks, perform risk management, and implement risk mitigation, as applicable
  • Manage audit activities (internal and external), including conducting vendor qualifications, establishing audit schedule, conducting audits, issuing an audit report, and closing out audits, as required.
  • Assist preparations for corporate partnership due diligence and health authority inspection-readiness programs
Requirements:

MINIMUM QUALIFICATIONS

  • Bachelor's degree (preferably in chemical engineering or life sciences) and 12+ years of related experience or equivalent combination of education and experience.
  • Extensive knowledge of GxP regulations, ICH Guidelines, FDA regulations and Guidance
  • Experience working with CDMOs, vendor selection, and management
  • Strong communication and interpersonal skills (maintain positive relationship and open communication)
  • Able to manage multiple projects, collaborate across various functional groups and manage workload independently
  • Ability to thrive in a dynamic environment with high level of agility; a wide degree of creativity and strategic thinking is expected
  • Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month. Please apply at elektrofi.com/careers.


EEOC Statement:

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.


To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.


All candidates must be legally authorized to work in the United States


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