Senior Manager of Quality Systems

Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology.

We are currently entering late-stage clinical trials and preparing for the commercialization and launch of our lead product candidate. We believe that each team member has the ability to impact and improve the lives of patients and that we are #BrighterTogether!

 

The Manager/Senior Manager of Quality Systems is a newly created role in our expanding Quality team. This role’s responsibilities will be split between developing, implementing, and operating the GXP Quality Management System (QMS) processes, and leading Veeva Vault activities to ensure the effective and compliant operation of the systems.

In this role, you will draft and implement GXP Governing Documents (Policies, SOPs, Work Instructions, etc.), and implement/facilitate the operation of the Veeva Quality Suite modules, such as Deviations/CAPA, Change Control, Vendor Management, and GXP Training. This will be done to support effective GXP operations, training, and compliance.

As a Veeva Super User, this hands-on position will partner across multiple functions (GXP and Regulatory) to directly support Veeva Vault system business owners and users in the installation, validation, deployment, user training, user account management, troubleshooting, and drafting of work-aids/internal guidance documents.

This position has excellent potential for demonstrating effective and creative project leadership and direct positive impact across functional areas. Reports into the GXP Quality department.

 

In this role you will:

  • Partner with the GXP functional teams to develop and issue effective GXP Governing Documents
  • Implement the effective operation of the Veeva Quality Vault eQMS process modules
  • Act as the lead Quality representative on the Veeva deployment team for the Regulatory and GXP applications, such as RIM, QualityDocs, eQMS, Training, etc.
  • Assist with User Acceptance Testing, and partner with Constellation IT, and with the Veeva deployment team in support of system validation, as needed.
  • Implement the Veeva Quality Vault Suite for the approval and management of GXP documents
  • Implement the Veeva Vault Training system, in support of the Training Program, Training Metrics and Reporting
  • Implement the Veeva eQMS system to enter, manage, track and report quality events, deviations, CAPA, Change Control, and GXP Vendor Management modules
  • Migrate existing GXP documents and training materials to the Veeva systems, once deployed
  • Develop and issue GXP Governing Documents (Policies, SOPs, Work Instructions, etc.), training materials, and internal job aids/guidelines for use of Veeva systems
  • Develop effective reports from the Veeva systems for tracking, trending, and reporting of Quality Metrics
  • Manage user permissions, and training of internal and external personnel on Veeva Vault systems
  • Be the primary internal contact with the Business Owners, users, and Constellation IT for Veeva related systems,

 

We are looking for people who:

  • Have a Bachelor’s degree in a relevant field (Computer Sciences, Biotechnology, Life Sciences, Engineering, etc.)
  • 5+ years of experience in the life sciences industry, preferably in Biotechnology, Pharmaceuticals, and or Medical Devices
  • Experience in GXP Quality systems (GMP, GCP, GVP, GLP, etc.)
  • Experience with Deviations/CAPA, Training Programs, GXP Vendor audits, and management of audit plans.
  • Direct experience in managing or working with eQMS, LMS, and Document Management Systems
  • SME proficiency in Veeva Vault Quality Docs, Training and eQMS, experience with Veeva RIM is desirable
  • Veeva Admin certification is desirable
  • Experience with other eQMS systems may be considered (e.g. Pilgrim, Master Control, Qualio, etc.)
  • Developed procedures and training materials in the GXP setting
  • Excellent written/verbal communication and collaboration skills
  • Enjoys working across functions to support and train staff at multiple levels

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Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.