GlaxoSmithKline
Director, Content Approval - Quality and Training
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
The
Director, Content Approval - Quality and Training
is a critical position within Global Medical Information and Content Approval. The Director will support the Senior Director of Quality, Training and Operations in the development, implementation and embedment of key training and capability initiatives to support the strategic objectives of content approval, including ABPI examination and certification and management monitoring. The role requires strong leadership, decision‑making, collaboration, vendor management and process implementation skills to enhance the efficiency, compliance and effectiveness of content approval deliverables. The Director serves as a key partner for both Medical Affairs and Commercial organizations.
Key Responsibilities Quality Oversight
Manage quality control processes, including established KPIs and SLAs, within content approval including ABPI examination and certification.
Identify, assess and execute/manage actions to mitigate risks associated with content approval operations.
Review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives. Recommend possible actions for continuous improvement.
Engage with GMI CA Leadership, team members and key business partners to identify opportunities for continuous improvements, share performance metrics and manage risks and mitigations.
Assist as a subject‑matter expert on the content approval process, serve as a key point of contact for audits and inspections, and manage remediation efforts related to content approval.
Develop and implement robust content approval management monitoring and ensure timely completion of relevant CAPAs.
Act as the
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 to drive adequate understanding and application of the same to ensure high quality and compliant content at GSK.
Training
Identify training needs and develop and deliver a comprehensive training strategy for Content Approval team members, ensuring alignment with internal processes and external regulatory requirements and business needs.
Ensure vendors for content review and approval have the necessary training on relevant GSK requirements/processes.
Develop, deliver and maintain a comprehensive onboarding curriculum for the Content Approval team members.
Partner with ABPI Directors, GMI CA leadership and internal stakeholders (e.g., Compliance, Legal, Regulatory, Commercial) to ensure training content remains current and relevant.
Conduct refresher training on content review and approval process, as needed, to ensure high quality and compliance.
Why You? Basic 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 across cross‑functional teams within a matrixed organization
Experience working at both global and local country levels
Flexible thinking – ability to analyze external environment and translate to strategy and gain support from others to implement a vision
Ability to work effectively with others, delegate appropriately and foster a strong culture of teamwork
Ability to execute and embed change initiatives
Demonstrate capabilities to assess situations, flex and adjust as required to meet the demands of the business
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1‑877‑694‑7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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Director, Content Approval - Quality and Training
is a critical position within Global Medical Information and Content Approval. The Director will support the Senior Director of Quality, Training and Operations in the development, implementation and embedment of key training and capability initiatives to support the strategic objectives of content approval, including ABPI examination and certification and management monitoring. The role requires strong leadership, decision‑making, collaboration, vendor management and process implementation skills to enhance the efficiency, compliance and effectiveness of content approval deliverables. The Director serves as a key partner for both Medical Affairs and Commercial organizations.
Key Responsibilities Quality Oversight
Manage quality control processes, including established KPIs and SLAs, within content approval including ABPI examination and certification.
Identify, assess and execute/manage actions to mitigate risks associated with content approval operations.
Review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives. Recommend possible actions for continuous improvement.
Engage with GMI CA Leadership, team members and key business partners to identify opportunities for continuous improvements, share performance metrics and manage risks and mitigations.
Assist as a subject‑matter expert on the content approval process, serve as a key point of contact for audits and inspections, and manage remediation efforts related to content approval.
Develop and implement robust content approval management monitoring and ensure timely completion of relevant CAPAs.
Act as the
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 to drive adequate understanding and application of the same to ensure high quality and compliant content at GSK.
Training
Identify training needs and develop and deliver a comprehensive training strategy for Content Approval team members, ensuring alignment with internal processes and external regulatory requirements and business needs.
Ensure vendors for content review and approval have the necessary training on relevant GSK requirements/processes.
Develop, deliver and maintain a comprehensive onboarding curriculum for the Content Approval team members.
Partner with ABPI Directors, GMI CA leadership and internal stakeholders (e.g., Compliance, Legal, Regulatory, Commercial) to ensure training content remains current and relevant.
Conduct refresher training on content review and approval process, as needed, to ensure high quality and compliance.
Why You? Basic 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 across cross‑functional teams within a matrixed organization
Experience working at both global and local country levels
Flexible thinking – ability to analyze external environment and translate to strategy and gain support from others to implement a vision
Ability to work effectively with others, delegate appropriately and foster a strong culture of teamwork
Ability to execute and embed change initiatives
Demonstrate capabilities to assess situations, flex and adjust as required to meet the demands of the business
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1‑877‑694‑7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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