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Labeling Implementation Manager (REMOTE ELIGIBLE)

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Wednesday, February 7, 2024

Job Description

The Labeling Implementation Manager is responsible for supporting pharmaceutical product artwork/labeling from initiation to implementation in a GMP environment. This role will support change control processes and compliance, drive continuous improvement projects, and build scalable processes for the future. The Manager will represent the Artwork team in cross functional settings and with external partners. They will support artwork/labeling updates and coordinate implementation activities from change initiation to supply chain implementation. With a key focus on compliance and quality, the Labeling Implementation Manager will ensure artwork changes are accurately assessed and implemented in a compliant and timely manner.

Key Duties & Responsibilities

  • Applies fundamental quality principles to artwork change management design, development, and process
  • Supports multiple stakeholders including Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to progress and prioritize artwork/label changes, and to drive improvement of artwork change management procedures
  • Acts as a resource for artwork/label change management and implementation activities
  • Demonstrates outstanding diligence and competence in change management
  • Supports strategy for change control development and impact assessment; develops robust, scalable processes for artwork implementation based on knowledge of best practices
  • Supports labeling change control meetings to ensure robust change assessment
  • Executes projects associated with product labeling and change control according to approved procedures, templates and standards, such as routing, tracking of document status, approval notifications, version control, format conversion, history record maintenance, distribution and archiving
  • Leads on time and implementation compliance of artwork into individual global markets
  • Represents Artwork/Labeling on cross functional teams
  • Fosters a culture of continuous improvement, innovation, and knowledge sharing within the team and across the organization
  • Implements and maintains metrics to measure diverse aspects of artwork and change management operations; leverages business analytics tools to compile reports and dashboards for effective communication of key trends and progress to all levels of the organization

Required Knowledge/Skills

  • Direct industry experience with change management processes in a GxP environment
  • Demonstrated capability to improve business processes
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • Excellent communication skills to explain change control strategy and the artwork process, and demonstrated ability to build consensus/alignment across a diverse set of stakeholders
  • Proven ability to build open and collaborative relationships
  • Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities

Education and Experience:

  • Bachelor's degree in relevant discipline
  • Typically requires 4 years of experience or the equivalent combination of education and experience

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at