Job Description

Remote Quality Systems & Compliance Manager/Sr. Manager
Cambridge, MA

What will you do?
The Manager/Sr. Manager, Quality Systems & Compliance, will be integral in supporting the vendor management and audit programs for all GxP functional areas at Blueprint Medicines. Reporting to the Associate Director of Quality Systems & Compliance, this individual will additionally be expected to cross-train, support, and individually contribute to the QMS and Quality infrastructure of the organization. This individual will be hands on with internal and external partners. This is an excellent opportunity to assist in the continuous growth and support of the Quality Systems and Compliance department through interaction with a variety of internal and external business partners across the GxP areas.

What will be your responsibilities?

• Manage the GxP Vendor and Audit programs at Blueprint medicines.
• Provide business administration, management, and user support within the Veeva QualityDocs and eQMS to GxP users.
• Ensure qualifications and training for auditors is complete and documented.
• Ensure vendor qualification status and documentation is maintained, archived, and updated in a timely manner through collaboration with business SMEs and development of tracking and management tools.
• Collaborate and assist GxP business partners in Quality System.

o Specific expertise will initially be focused in vendor records, quality agreements, audit
workflows, and findings/CAPAs.

• Contribute to the development of continuous improvement of Quality Systems and SOPs.
• Contribute to the development of risk-based auditing schedules of CxO and internal GxP departments.
• Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions with internal and external auditees, where applicable.
• Assist with managing Inspections of Blueprint Medicines
• Assist with establishing Quality Systems metrics and routinely reporting to senior management.
• Participate in Veeva Vault process improvements projects, system configuration changes, and associated validation (UAT) activities applicable to modules used routinely (vendor/audit workflows).
• Collaborate and assist GxP business partners in Quality System.

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What qualifications do we require?*

• B.S degree in life sciences, chemistry with a minimum of 10 years of experience of quality management system experience with progressive responsibility in a lead or managerial capacity.
• Extensive knowledge of GxP and Quality principles, practices, and standards
• Strong knowledge of global regulations (EU, US)
• Excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers.
• Demonstrated ability to work independently and in a team environment and seek resources as necessary
• Demonstrated effective time management skills
• Strong professionalism and interpersonal skills
• Ability to effectively prioritize and manage multiple projects and tasks.
• At home in a results-driven, highly accountable environment where you can make a clear impact.
• A team player, who listens effectively and invites response and discussion.
• A collaborator who communicates in an open, clear, complete, timely and consistent manner.