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Senior Manager of Quality Systems/Supplier Quality

Company: Loves Furniture
Location: Cambridge
Posted on: April 8, 2021

Job Description:

Position: Senior Manager, Quality Systems / Supplier Quality Location: Cambridge, MA
Job Id: 210205 # of Openings: 1 Summary:-- Solid's Start: Solid is the English translation of Eytan, the Hebrew name of Solid's co-founders Ilan and Annie Ganot's son, Eytani, who was diagnosed with Duchenne muscular dystrophy (Duchenne) in 2012 at the age of 3. Unsatisfied with the existing Duchenne treatment landscape, the Ganots built a disease-focused company with the people and potential to advance innovative science quickly and responsibly. Solid's Culture:--Much of what you can learn about Solid and our culture can be found in our name. We come to work each day for the Duchenne community, and that community is our family. We have a collective strength and determination that propels us to embrace innovation and challenge the status quo because central to all that we do is the unwavering commitment to advance meaningful therapies for the Duchenne community. We are a fiercely passionate and committed team, driven to collaborate with thoughtfulness and respect. We value exceptional skills, scientific curiosity, entrepreneurial spirit, diversity and adaptability. #TogetherWeAreSolid in our mission to find a cure for Duchenne muscular dystrophy and we will not stop until we've done it. Solid Biosciences is looking for a Senior Manager of Quality Systems/Supplier Quality who will be responsible for the qualification and management of GxP supplier and contractor relationships. This includes, ensuring compliance of our external partners (GMP production sites, GxP testing sites, clinical partners, and service providers) through qualification, audits, metrics, and relationship-building. This person will work closely with members of the Quality Team, Technical Operations organization, and Clinical Team to develop and utilize phase-appropriate systems which ensure appropriate and risk-based oversight of Solid Bioscience's supplier network. Key Duties & Accountabilities:

  • Manage, execute, and maintain the supplier qualification and change notification process
  • Provide Quality oversight of GxP external manufacturing, testing, and storage/distribution partners including establishment and maintenance of quality agreements
  • Develop, maintain, and execute an Audit schedule of current partners; audit potential new partners as part of the supplier qualification process
  • Develop, maintain, and execute an Internal Audit schedule
  • Lead both internal and external Quality Audits; Evaluated and prepare internal departments for GxP Inspection Readiness
  • Develop and deliver GxP training for Quality Assurance processes and procedures
  • Provide Quality guidance and support for Change Controls, CAPAs and Investigations
  • Author, review, and approve quality policies, SOPs, and work instructions for areas of responsibility
  • Monitor performance metrics and drive continuous improvement (external partners and internal processes)
  • Perform other related QA duties and ad hoc projects as required by position
  • Judgment and Decision Making
  • Internal and External Communication - oral, written and presentations
  • Technical writing
  • Attention to Detail
  • Self-motivated Knowledge, Education, Experience & Skills:
    • Bachelor's degree with 7+ years' experience in biotechnology or pharmaceutical industry; 5+ years Quality experience; equivalent experience and education will be considered
    • Demonstrated experience managing GxP suppliers, including production of supplier metrics and independent supplier quality audits
    • Understanding of GMP and GCP regulations and guidance documents
    • Experience in helping to build and maintain a Quality infrastructure Travel commitment:--Travel required approximately 30%, dictated by supplier audits (Post Covid)

Keywords: Loves Furniture, Cambridge , Senior Manager of Quality Systems/Supplier Quality, Executive , Cambridge, Massachusetts

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