Sr. QA Manager, Supplier Quality jobs in United States
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Lykan Bioscience - Now RoslinCT · 1 day ago

Sr. QA Manager, Supplier Quality

positionHopkinton, MA, US
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
money$130K/yr - $170K/yr
date8+ years exp

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. The Senior QA Manager, Supplier Quality is responsible for supporting the development, implementation, and ongoing management of Supplier Quality Programs.

BiotechnologyManufacturing

Responsibilities

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 KPls as part of Quality Management Review
Mentor personnel within QA and cross functionally on Supplier Quality Systems to promote a quality culture
Other duties as assigned

Qualification

Supplier Quality ManagementQuality AuditsCGMP RegulationsQuality Systems ImplementationContinuous Improvement InitiativesMicrosoft Office SuiteTeam OrientationProblem-solvingCommunication Skills

Required

8+ years relevant Supplier Quality experience in a pharma/biotech company, working within a Quality System and regulated GMP environment
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint)
Effective problem-solving capabilities
Strong oral and written communication skills
Must be team oriented
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

Preferred

Quality Audit certifications a plus
Cell therapy experience a plus
Previous management experience preferred

Benefits

Flexible and empowering work environment
Attractive benefits package
Emphasis on work-life balance

Company

Lykan Bioscience - Now RoslinCT

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RoslinCT is a leading global contract development and manufacturing services organization (CDMO) focused on Advanced Cell and Gene Therapies.
dateFounded in 2019
location
Hopkinton, Massachusetts, USA
people-size201-500 employees
web-link
https://www.lykanbio.com

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
GHO CapitalWindRose Health Investors
2022-08-04Private Equity
2022-08-04Acquired
2019-06-04Private Equity

Leadership Team

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Keith McCormick
Chief Financial Officer
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Recent News

pleasantbaycp.com
Portfolio
2024-02-08
ghocapital.com
RoslinCT and Lykan Bioscience Combine to Create Leading Advanced Cell Therapy CDMO
2024-02-08
williamblair.com
Lykan Bioscience Has Merged with RoslinCT
2024-02-08
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