GlaxoSmithKline
Senior Director, Strategic Product Quality
GlaxoSmithKline, Rockville, Maryland, us, 20849
Senior Director, Strategic Product Quality
Site Name:
Durham Blackwell Street, UK - Hertfordshire - Ware, UK - London - Brentford, USA - Maryland - Rockville, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper ProvidencePosted Date:
May 17 2023The Sr. Director of Product Quality is accountable for overseeing, managing, and directing the efforts of multiple matrix Quality leaders (Product Quality Leaders (PQLs)) in support of commercialization efforts of a portfolio of small molecule and/or large molecule programs within the Strategic Product Quality (SPQ) organization. You will provide guidance and strategic direction to staff in their efforts to lead Product Quality Teams in support of end-to-end quality oversight of assigned programs throughout clinical development, commercialization, regulatory filing submissions and response to questions, PAI inspection preparation, product launch, and post approval lifecycle management activities. This oversight includes proactively establishing Quality strategies in alignment with GSK's Quality Plan, industry practices, and/or regulatory trends.The candidate will be a core member of the SPQ leadership team and will be critical in organizational and key talent development. You will help establish and drive overall department strategic priorities, process improvements, and establish and monitor metrics in support of overall product development goals and product quality risks. The ideal candidate should have experience in CMC development and commercialization of various modalities (i.e. small molecules, ADCs, oligonucleotides, mAbs, therapeutic proteins, etc.) and have experience working with medical devices and combination products. Experience in developing and influencing regulatory strategies during clinical and commercial filings, response to questions, post approval submissions, and regulatory briefing communications is required.Key Responsibilities:Lead and direct the efforts of assigned staff in support of GSK's Quality Plan.Provide clear direction for overall Product Quality strategies for the assigned program portfolio.Critically evaluate new products and processes with respect to Quality and compliance requirements.Partner effectively with technical functions (R&D, Analytical, MSAT, RA CMC) and operational functions (manufacturing, site QA/QC) to ensure robust product development, new product introduction, and life-cycle management/improvements are executed per appropriate quality, compliance, technical, regulatory, and industry expectations.Identify and escalate cross program risks and proactively work with project teams and key stakeholders to mitigate such risks during development.Lead/Co-sponsor key improvement projects per department goals or Quality Plan objectives across multiple sites and/or products as required.Chair and/or participate in appropriate governance meetings as required.Critically review and approve (where applicable) relevant regulatory documents, including but not limited to CMC clinical and commercial regulatory submissions, briefing booklets, information requests, etc.Proactively represent and promote GSK's Quality strategy externally through industry advocate efforts and other forums.Support device development for combination products (as needed) by participating in design history file reviews, strategy, risk identification, and risk mitigation.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Master's degree in biological sciences, chemistry, pharmacy or related field.10+ years of experience in CMC Development of both small molecules and large molecules, including significant tenure in a quality, compliance, and/or regulatory role.Experience with authoring, reviewing, and approving Regulatory filings for both clinical and commercial programs.Knowledge of cGMPs, FDA guidelines and international guidelines dealing with pharmaceutical manufacturing and quality assurance.Preferred Qualifications:If you have the following characteristics, it would be a plus:Key areas of expertise include developing product quality control strategies.Sound understanding of product development, process characterization, process validation, troubleshooting, and investigation support of routine manufacturing.Previous experience on a Quality Leadership Team (operational site or central team).Sound and timely decision-making and problem-solving skills in high impact situations.Extensive understanding of product development lifecycle pertaining to API/DS, DP, and analytical development.Demonstrated team leadership capabilities. Able to motivate and influence direct reports as well as other key stakeholders indirectly in support of overall Quality plan objectives and improvements.Able to influence senior stakeholders to implement change.Experience with multiple global regulatory authorities for major markets.Leader and mentor to other matrix leaders who represent all of Quality to global CMC teams.Quality technical expert who can clearly develop quality strategy with assigned staff, and communicate such strategy to technical functions across GSK.Knowledge and experience with pharmaceutical product development in both small and large molecule commercialization, and associated project management and governance.Operational Excellence skills.Working knowledge of the application of statistical techniques to Quality processes.Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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Site Name:
Durham Blackwell Street, UK - Hertfordshire - Ware, UK - London - Brentford, USA - Maryland - Rockville, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper ProvidencePosted Date:
May 17 2023The Sr. Director of Product Quality is accountable for overseeing, managing, and directing the efforts of multiple matrix Quality leaders (Product Quality Leaders (PQLs)) in support of commercialization efforts of a portfolio of small molecule and/or large molecule programs within the Strategic Product Quality (SPQ) organization. You will provide guidance and strategic direction to staff in their efforts to lead Product Quality Teams in support of end-to-end quality oversight of assigned programs throughout clinical development, commercialization, regulatory filing submissions and response to questions, PAI inspection preparation, product launch, and post approval lifecycle management activities. This oversight includes proactively establishing Quality strategies in alignment with GSK's Quality Plan, industry practices, and/or regulatory trends.The candidate will be a core member of the SPQ leadership team and will be critical in organizational and key talent development. You will help establish and drive overall department strategic priorities, process improvements, and establish and monitor metrics in support of overall product development goals and product quality risks. The ideal candidate should have experience in CMC development and commercialization of various modalities (i.e. small molecules, ADCs, oligonucleotides, mAbs, therapeutic proteins, etc.) and have experience working with medical devices and combination products. Experience in developing and influencing regulatory strategies during clinical and commercial filings, response to questions, post approval submissions, and regulatory briefing communications is required.Key Responsibilities:Lead and direct the efforts of assigned staff in support of GSK's Quality Plan.Provide clear direction for overall Product Quality strategies for the assigned program portfolio.Critically evaluate new products and processes with respect to Quality and compliance requirements.Partner effectively with technical functions (R&D, Analytical, MSAT, RA CMC) and operational functions (manufacturing, site QA/QC) to ensure robust product development, new product introduction, and life-cycle management/improvements are executed per appropriate quality, compliance, technical, regulatory, and industry expectations.Identify and escalate cross program risks and proactively work with project teams and key stakeholders to mitigate such risks during development.Lead/Co-sponsor key improvement projects per department goals or Quality Plan objectives across multiple sites and/or products as required.Chair and/or participate in appropriate governance meetings as required.Critically review and approve (where applicable) relevant regulatory documents, including but not limited to CMC clinical and commercial regulatory submissions, briefing booklets, information requests, etc.Proactively represent and promote GSK's Quality strategy externally through industry advocate efforts and other forums.Support device development for combination products (as needed) by participating in design history file reviews, strategy, risk identification, and risk mitigation.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Master's degree in biological sciences, chemistry, pharmacy or related field.10+ years of experience in CMC Development of both small molecules and large molecules, including significant tenure in a quality, compliance, and/or regulatory role.Experience with authoring, reviewing, and approving Regulatory filings for both clinical and commercial programs.Knowledge of cGMPs, FDA guidelines and international guidelines dealing with pharmaceutical manufacturing and quality assurance.Preferred Qualifications:If you have the following characteristics, it would be a plus:Key areas of expertise include developing product quality control strategies.Sound understanding of product development, process characterization, process validation, troubleshooting, and investigation support of routine manufacturing.Previous experience on a Quality Leadership Team (operational site or central team).Sound and timely decision-making and problem-solving skills in high impact situations.Extensive understanding of product development lifecycle pertaining to API/DS, DP, and analytical development.Demonstrated team leadership capabilities. Able to motivate and influence direct reports as well as other key stakeholders indirectly in support of overall Quality plan objectives and improvements.Able to influence senior stakeholders to implement change.Experience with multiple global regulatory authorities for major markets.Leader and mentor to other matrix leaders who represent all of Quality to global CMC teams.Quality technical expert who can clearly develop quality strategy with assigned staff, and communicate such strategy to technical functions across GSK.Knowledge and experience with pharmaceutical product development in both small and large molecule commercialization, and associated project management and governance.Operational Excellence skills.Working knowledge of the application of statistical techniques to Quality processes.Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
#J-18808-Ljbffr