myGwork - LGBTQ+ Business Community · 3 days ago

Senior Director, Packaging and Labeling Quality Operations

Boston, MA

Full-time

Hybrid

Director

12+ years exp

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Responsibilities

Establish robust Quality Processes/Process Ownership for 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

Qualification

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Packaging requirementsLabeling requirementsRisk-based quality principlesProgram managementEnterprise risk managementRoot cause analysisLeanDmaicSix sigmaProblem-solvingStrategic planningLeadershipTeam development

Required

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

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

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