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Supplier Quality Assurance Manager

Company: Lykan Bioscience
Location: Hopkinton
Posted on: June 23, 2022

Job Description:

WHO WE ARELykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.OUR PASSIONWorking at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do.THE LYKAN WAYHere at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.ACCELERATING YOUR FUTURE The Manager of Supplier Quality is responsible to support the development, implementation, and on-going management of Supplier Quality Programs. The ideal candidate is a self starter with experience in a start up environment.HOW YOU WILL MAKE AN IMPACT

  • Manage and further develop the Supplier Quality Program
  • Manage and conduct Supplier Audits
  • Manage the Supplier Qualification activities including classification evaluation, quality agreements and quality questionnaires; further development with peers
  • Manage Supplier Change Notification (SCN) Program
  • Manager Supplier Corrective Action Requests and Notifications (Support creation and management of supplier investigations)
  • Develop programs, workflows and standard operating procedures for the Supplier Quality program.
  • Monitor implementation of Supplier Quality programs, ensuring compliance to SOPs and identifying areas for improvement
  • Support implementation and training of associated systems
  • Act as Supplier Quality SME for NCMRs (Non-conforming Material Requests)
  • Assist Quality Systems during health authority inspections and client audits
  • Review/Approve Deviations, Change Controls and CAPAs as necessary
  • Contribute to development of Key Performance Indicators that measure effectiveness of QMS and assist with tracking and trending of Supplier Quality data
  • Support reporting of KPIs as part of Quality Management Review
  • Mentor personnel within QA and cross functionally on Supplier Quality Systems to promote a quality cultureQualifications
    • 8+ years relevant Supplier Quality experience in a pharma/biotech company, working within a Quality System and regulated GMP environment. Cell therapy experience a plus
    • Quality Audit certifications a plus
    • Prior experience with implementing quality systems and/or continuous improvement initiatives focused on Quality Systems and Supplier Quality
    • Must be team oriented; previous management experience preferred
    • Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
    • Ability to work independently to meet objectives and timelines
    • Ability to make decisions of moderate/high complexity independently and escalate complex decisions as needed.
    • Well versed in cGMP and ICH regulations/ guidelines
    • Domestic and International travel will be required
    • Must be able to perform in person and/or virtual audits OUR COMMITMENTAll Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Keywords: Lykan Bioscience, Worcester , Supplier Quality Assurance Manager, Executive , Hopkinton, Massachusetts

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