GSK
Director, Content Approval - Quality and Training
GSK, Collegeville, Pennsylvania, United States, 19426
Overview
Director, Content Approval - Quality and Training at GSK. The Director will support the Sr Director of Quality, Training and Operations in developing, implementing and embedding key training and capability initiatives to support content approval objectives, including ABPI examination and certification and management monitoring. The role requires strong leadership, decision-making, collaboration, vendor management, management monitoring and process implementation skills to enhance the efficiency, compliance, and effectiveness of content approval deliverables. The Director serves as a key partner for Medical Affairs and Commercial organizations. Key Responsibilities
Quality Oversight: manage quality control processes (including established KPI and SLAs where applicable) within content approval including ABPI examination and certification; identify, assess and execute actions to mitigate risks; review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives; engage with GMI CA Leadership, team members and key business partners to identify opportunities for continuous improvements, share performance metrics and manage risks & mitigations; assist as a subject matter expert on content approval processes, serve as a point of contact for audits and inspections, and manage remediation efforts; develop and implement robust content approval management monitoring and ensure timely completion of CAPAs; act as deputy global process owner for the process of approval of promotional and non-promotional materials and partner with the global process owner to ensure the process is optimal and widely understood to ensure high quality and compliant content at GSK. Training: identify training needs and develop and deliver a comprehensive training strategy for the Content Approval team; ensure vendors for content review and approval have the necessary training on relevant GSK requirements/processes; develop, deliver and maintain onboarding curriculum; partner with ABPI Directors, GMI/CA leadership and internal stakeholders to ensure training content remains current and relevant; conduct refresher training as needed to ensure high quality and compliance. Qualifications
Master’s/Graduate Degree in Life Sciences or Healthcare 6+ years of pharmaceutical industry experience 3+ years of Medical Affairs experience Strong understanding of content approval requirements including external regulations (e.g., ABPI Code) Experience in quality and compliance oversight including audits and inspections Experience in the development and delivery of training and onboarding programs Preferred Experience
Experience in digital transformation and technology solutions to enhance training and operations Leadership experience in cross-functional teams within a matrixed organization Experience of working at both global and local country level Flexible thinking with ability to analyze external environment and translate to strategy and gain support to implement a vision Ability to work effectively with others, delegate appropriately and foster teamwork Ability to execute and embed change initiatives Demonstrate capabilities to assess situation, adapt and adjust as required to meet business demands Why GSK
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade and focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture emphasizes being ambitious for patients, accountable for impact and doing the right thing. EEO and Accommodation
GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply, contact the GSK Service Centre. GSK does not accept referrals from employment businesses/agencies without prior written authorization. GSK may be required to report expenses to comply with US Transparency requirements.
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Director, Content Approval - Quality and Training at GSK. The Director will support the Sr Director of Quality, Training and Operations in developing, implementing and embedding key training and capability initiatives to support content approval objectives, including ABPI examination and certification and management monitoring. The role requires strong leadership, decision-making, collaboration, vendor management, management monitoring and process implementation skills to enhance the efficiency, compliance, and effectiveness of content approval deliverables. The Director serves as a key partner for Medical Affairs and Commercial organizations. Key Responsibilities
Quality Oversight: manage quality control processes (including established KPI and SLAs where applicable) within content approval including ABPI examination and certification; identify, assess and execute actions to mitigate risks; review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives; engage with GMI CA Leadership, team members and key business partners to identify opportunities for continuous improvements, share performance metrics and manage risks & mitigations; assist as a subject matter expert on content approval processes, serve as a point of contact for audits and inspections, and manage remediation efforts; develop and implement robust content approval management monitoring and ensure timely completion of CAPAs; act as deputy global process owner for the process of approval of promotional and non-promotional materials and partner with the global process owner to ensure the process is optimal and widely understood to ensure high quality and compliant content at GSK. Training: identify training needs and develop and deliver a comprehensive training strategy for the Content Approval team; ensure vendors for content review and approval have the necessary training on relevant GSK requirements/processes; develop, deliver and maintain onboarding curriculum; partner with ABPI Directors, GMI/CA leadership and internal stakeholders to ensure training content remains current and relevant; conduct refresher training as needed to ensure high quality and compliance. Qualifications
Master’s/Graduate Degree in Life Sciences or Healthcare 6+ years of pharmaceutical industry experience 3+ years of Medical Affairs experience Strong understanding of content approval requirements including external regulations (e.g., ABPI Code) Experience in quality and compliance oversight including audits and inspections Experience in the development and delivery of training and onboarding programs Preferred Experience
Experience in digital transformation and technology solutions to enhance training and operations Leadership experience in cross-functional teams within a matrixed organization Experience of working at both global and local country level Flexible thinking with ability to analyze external environment and translate to strategy and gain support to implement a vision Ability to work effectively with others, delegate appropriately and foster teamwork Ability to execute and embed change initiatives Demonstrate capabilities to assess situation, adapt and adjust as required to meet business demands Why GSK
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade and focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most. Our culture emphasizes being ambitious for patients, accountable for impact and doing the right thing. EEO and Accommodation
GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply, contact the GSK Service Centre. GSK does not accept referrals from employment businesses/agencies without prior written authorization. GSK may be required to report expenses to comply with US Transparency requirements.
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