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Senior Director, Packaging and Labeling Quality Operations (Hybrid)

Semma Therapeutics

Semma Therapeutics

Sales & Business Development, Operations, Quality Assurance
Boston, MA, USA
Posted on Saturday, September 30, 2023

Job Description

General Summary:

The Sr. Director of Packaging and Labelling Operational Quality will advance compliance oversight for packaging and labelling validation, commercial supply, and product launches in North America and worldwide across the Small Molecule portfolio. The Sr. Director will have a broad role working with stakeholders across Manufacturing, Supply Chain and Regulatory. The role will support International global expansion product launches and assessment of product requirements including labelling requirements in local countries/affiliates.

The Sr. Director is responsible for oversight of department activities, technical development of personnel and ensuring the quality of deliverables within the role's purview. The incumbent is known for significant technical expertise and establishes the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.

The Sr. Director will foster strong collaboration and partnership from the team with external and internal stakeholders, and the International Quality leadership team. The individual will partner with CDMOs ensuring quality operations and advancing improvements as necessary.

Key Duties and Responsibilities:

  • Establish robust Quality Processes/Process Ownership for the packaging and labelling validation and re-supply as well as commercial product launches and late phase customization processes

  • Develop project plans for all projected product launches and manage cross functional discussions and label requirements for each region

  • 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

  • Provide leadership and partner with QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution

  • Partner with stakeholders across enabling functions for alignment of strategies, and optimization of programs for delivery, specifically with respect business deliverables vs. QA-specific initiatives

  • Establish and direct development of Quality Metrics to support process improvement activities

  • Develop plan and lead Quality team to enable support for future small molecule portfolio advancement

  • Develop team to for individual and function growth

  • Build highly functional relationships with CDMO Quality leadership to influence compliance performance and ensure Quality Agreement expectations

  • Business travel can be up to 30% of time

Knowledge and Skills:

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

  • Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model

  • Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness

  • Knowledge of packaging and labeling requirements in the US, EU and rest of world.

  • Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment

  • Demonstrated strategic planning and execution skills required

  • Developing individuals and teams; proven leadership capabilities within multi-level organization

  • Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness

  • Operational Excellence experience with proven ability to lead improvement projects-Experience with implementation and execution of program and enterprise risk management, Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma

  • Demonstrate Vertex Phenotype qualities

Education and Experience:

  • Bachelor's degree in a scientific or allied health field (or equivalent degree)
  • Typically requires 12 years of work experience and 5 years of management experience, or the equivalent combination of education and experience

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