Planet Pharma
Senior QA Technical Manager
Planet Pharma, Alameda, California, United States, 94501
Job DescriptionSUMMARY/JOB PURPOSE:
This position is responsible for executing assigned tasks, including applying Quality tools and metrics to drive continuous improvement across a variety of systems and projects. This individual has knowledge of DMAIC, SIPOC, FMEA, Fishbone, and other systematic approaches to improve systems. The successful candidate will generate feasible solutions as a Subject Matter Expert (SME) and partner with key stakeholders as requested. This role generates or maintains, as applicable, sustainable, robust, and lean Quality Systems. Communicates TE reporting and documenting requirements to stakeholders. Reviews and approves TEs for accuracy and completeness. Provides feedback and guidance to stakeholders on the TE reports. Depending on the assigned project, the successful candidate supports the Strategic Quality Team and stakeholders to assure alignment, including CMC, Production and Supply Chain, Clinical Operations, Legal, as applicable. This role collaborates on improvement projects. The successful candidate would be responsible for maintaining or implementing processes that harmonize across platforms, create reasonable implementation plans, and use their knowledge and experience to troubleshoot, measure, and adjust accordingly. Demonstrated ability to apply a risk-based approach is highly recommended.As QA Core, supports QA Partners.Essential Duties And Responsibilities:Responsible for maintaining or improving Quality systems and projects using lean six sigma tools, as assigned.Supports driving change and drives for results.Works on key projects to close gaps and supports driving the business forward.Ensures compliance with applicable health authority regulations and guidelines.Responsible for writing SOPs in relation to the project as required.Ability to troubleshoot current state, propose both small and large changes, using quality risk management concepts and tools.SUPERVISORY RESPONSIBILITIES:No supervisory responsibility.Education/Experience/Skills:Education:Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, IT, engineering, industrial engineering, or a related field.Experience:Minimum of 10-12 years of relevant experience in pharmaceutical/biotech.Quality Specialist 0-12 years.Six sigma black belt or equivalent preferred.Knowledge/Skills/Abilities:Deep knowledge and understanding of the Quality tools used to drive process refinement and continuous improvement for Quality systems that align with Global Health Authority requirements and regulations related to GxP.Demonstrated experience in applying Quality tools (DMAIC, FMEA, SIPOC, Risk management) to various situations where measurable improvement was achieved.Possesses broad expertise and/or unique knowledge and skills to contribute to the business analysis of translating current paper systems to automated platforms.Ability to deliver on company goals with measurable impact and outcomes.Proven excellent written and oral communication skills, able to translate complex concepts across all levels of the organization.Demonstrated ability to apply strong analytical thinking to develop technical and/or business solutions to complex problems.Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.Interprets, executes, and recommends modifications or additions to company policies and/or divisional programs as requested.Ability to work under tight timelines with right first-time results.JOB COMPLEXITY:This role is a support role. Engages others to achieve a goal.The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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This position is responsible for executing assigned tasks, including applying Quality tools and metrics to drive continuous improvement across a variety of systems and projects. This individual has knowledge of DMAIC, SIPOC, FMEA, Fishbone, and other systematic approaches to improve systems. The successful candidate will generate feasible solutions as a Subject Matter Expert (SME) and partner with key stakeholders as requested. This role generates or maintains, as applicable, sustainable, robust, and lean Quality Systems. Communicates TE reporting and documenting requirements to stakeholders. Reviews and approves TEs for accuracy and completeness. Provides feedback and guidance to stakeholders on the TE reports. Depending on the assigned project, the successful candidate supports the Strategic Quality Team and stakeholders to assure alignment, including CMC, Production and Supply Chain, Clinical Operations, Legal, as applicable. This role collaborates on improvement projects. The successful candidate would be responsible for maintaining or implementing processes that harmonize across platforms, create reasonable implementation plans, and use their knowledge and experience to troubleshoot, measure, and adjust accordingly. Demonstrated ability to apply a risk-based approach is highly recommended.As QA Core, supports QA Partners.Essential Duties And Responsibilities:Responsible for maintaining or improving Quality systems and projects using lean six sigma tools, as assigned.Supports driving change and drives for results.Works on key projects to close gaps and supports driving the business forward.Ensures compliance with applicable health authority regulations and guidelines.Responsible for writing SOPs in relation to the project as required.Ability to troubleshoot current state, propose both small and large changes, using quality risk management concepts and tools.SUPERVISORY RESPONSIBILITIES:No supervisory responsibility.Education/Experience/Skills:Education:Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, IT, engineering, industrial engineering, or a related field.Experience:Minimum of 10-12 years of relevant experience in pharmaceutical/biotech.Quality Specialist 0-12 years.Six sigma black belt or equivalent preferred.Knowledge/Skills/Abilities:Deep knowledge and understanding of the Quality tools used to drive process refinement and continuous improvement for Quality systems that align with Global Health Authority requirements and regulations related to GxP.Demonstrated experience in applying Quality tools (DMAIC, FMEA, SIPOC, Risk management) to various situations where measurable improvement was achieved.Possesses broad expertise and/or unique knowledge and skills to contribute to the business analysis of translating current paper systems to automated platforms.Ability to deliver on company goals with measurable impact and outcomes.Proven excellent written and oral communication skills, able to translate complex concepts across all levels of the organization.Demonstrated ability to apply strong analytical thinking to develop technical and/or business solutions to complex problems.Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.Interprets, executes, and recommends modifications or additions to company policies and/or divisional programs as requested.Ability to work under tight timelines with right first-time results.JOB COMPLEXITY:This role is a support role. Engages others to achieve a goal.The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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