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Manager, GMP Operational Quality (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Boston, MA, USA
Posted on Tuesday, June 11, 2024

Job Description

GENERAL POSITION SUMMARY:

The Quality Manager is recognized as an expert in the principles and application of quality and regulatory compliance. The Quality Manager is responsible for the oversight of packaging and labeling activities and Quality relationship with CDMOs of commercial products. The position manages multiple projects simultaneously ensuring alignment with business timelines, corporate goals, and compliance. This role works closely with business partners and stakeholders to ensure uninterrupted supply of Vertex products.

Key Responsibilities:

The responsibilities of this position include, but are not limited to, the following:

  • Develop and manage relationships with strategic internal and external partners in support of Vertex’s expanding commercial portfolio to ensure compliant operations and continued supply.
  • Negotiate Quality Agreements and monitor performance to agreement expectations.
  • Support Packaging and Labeling validation and Product Launch to ensure successful product commercialization.
  • Oversight of Artwork initial approval and changes. Ensure proper assessments have been completed and timing of labeling changes meets expectations.
  • Assessment and approval of Commercial Change Controls. Ensure strategy for supply and disposition are defined and executed.
  • Responsible for Escalation of events, as needed. Drive investigations and prepare communication for leadership.
  • Provide Quality guidance for root-cause analysis and product impact assessment for investigations ensuring appropriate CAPA actions are identified.
  • Perform review and disposition activities for Finished Goods in support of Commercial product. Drive completion of disposition to meet agreed turnaround times. Work closely with Supply chain to ensure alignment on priorities, as necessary.
  • Represent Quality on project teams for continuous improvements or supporting business growth.
  • Provide Audit / Inspection support as an SME.

Minimum qualifications:

Bachelor’s degree in a scientific or allied health field with 5+ years of relevant work experience, or the equivalent combination of education and experience.

**Travel approximately 25%**

Preferred Qualifications:

  • Broad GMP knowledge and understanding across lifecycle of the product
  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Project Management / Continuous Improvement
  • Ability to lead and manage projects/teams within corporate objectives and project timelines
  • Proficient in utilizing project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
    • Demonstrated ability to work independently to provide QA support for large, multifaceted projects
  • Collaboration / Teamwork / Conflict Management
    • Ability to independently lead cross-functional teams and represent the Quality unit
    • Ability to understand and translate business needs
    • Recognized as a mentor with a strong ability to transfer technical knowledge and teach skills to junior staff
  • Critical Thinking / Problem Solving
    • Ability to evaluate quality matters and make decisions utilizing risk based approach
  • Flexibility/Adaptability
  • Attention to detail
  • Sense of urgency- ability to act quickly/escalation process/transparency

    Hybrid-Eligible Roles

    In this Hybrid-Eligible role, you can choose to be designated as:

  • Hybrid: work remotely up to two days per week; or select
  • On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND2

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 ApplicationAssistance@vrtx.com.