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Associate Director, Quality Packaging and Labeling Quality Operations (Cell and Gene)

Semma Therapeutics

Semma Therapeutics

Operations, Quality Assurance
Boston, MA, USA
Posted on Tuesday, August 15, 2023

Job Description

General Summary:

The Associate Director, Packaging and Labeling, Quality Operations is responsible for the quality oversight of critical components Contract Development and Manufacturing Organizations (CDMOs) for Cell & Genetic Programs through the lifecycle development process. This includes quality oversight for the selection, qualification and routine monitoring of Contract manufacturers and laboratories. The quality role will closely partner with operational stakeholders and participate in associated governance for the successful planning and execution of program CMC strategy. The successful candidate will be a key member of the Vertex Cell & Genetic Therapy Quality Team

The role is responsible for collaborating with internal stakeholders to develop and maintain relationships and drive compliance and continuous improvement activities within critical component contract manufacturers and associated laboratories.

Key Duties and Responsibilities:

  • Be the Quality expert for Packaging and Labeling, spanning life cycle management within the Cell & Genetic programs program.

  • Participate in Geographic Expansion activities and product launch risk assessments to ensure that Quality related actions are planned into projects and completed in line with the commitments.

  • Quality responsibilities includes maintaining quality oversight as follows:

  • Participate, support and oversight for strategic life cycle of packaging and labeling.

  • Establishment of vendor quality oversight processes including qualification, risk categorization and routine monitoring.

  • Negotiate, monitor, and maintain Quality Agreements with vendors.

  • Life cycle management of labels, label qualification - thermal, mechanical, stability, performance, etc.

  • Management of artwork, revisions, implementation at CDMOs.

  • Oversight of Systems associated with artwork specifications and content, and label controls.

  • Responsible for the quality review and approval of critical component change controls for development and commercial processes, assess impact and implementation activities.

  • Participate in cross functional teams to align packaging & labeling platforms, development workflows, and operational efficiencies, and determine enhancements.

  • Provides quality expertise and leadership to resolve critical issues.

  • Monitors quality processes, metrics, identification of compliance gaps and drive quality remediation and continuous improvement activities.

  • Build strategic relationships with vendors and CDMOs within the Quality organization and participates in Business Review Meetings to ensure Quality issues are raised and addressed, as necessary.

  • Participate in Cell & Genetic Program and Quality projects.

Knowledge and Skills:

  • In-depth knowledge, and experience across GMPs life cycle in Cell & Gene therapy.

  • Experience in product life cycle from discovery to commercials product development for packaging and labeling

  • Knowledge of packaging and labeling requirements in the US, EU, and rest of world Knowledge (including ISO, ISTA, ASTM, etc.)

  • Broad understanding of regulatory environment including quality systems, compliance, and strategy.

  • Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

  • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

  • Ability to apply risk management principles to decision making and operational priorities.

  • Critical Thinking and Problem Solving skills

  • Strong leadership and an innate ability to collaborate and build relationships.

Education and Experience:

  • Bachelor's degree in a Biotech/Bioengineering/ Lifesciences field.

  • Master's degree or relevant comparable background.

  • Typically requires 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

1. On-Site and work 5 days per week with ad hoc flexibility;

2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select

#LI-AR1 #LI-Hybrid

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.