CASY-MSCCN Jobs

Reference #: 407520 Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Oct 29 2024

Team Lead, TA Quality

Job Purpose The position is responsible for leading a team of Quality Business Partner that deliver independent quality expert support to stakeholder. The incumbent is a member of the QBP Therapeutic Area LT and provides input into the quality strategy of this function. The position is responsible for ensuring that quality is designed into programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness.

Key Responsibilities

Functional Expertise: Continually evaluate the strategic approach, drive changes in R&D QuRE processes and modify the quality strategy and plan to meet the changing needs to the organization, regulatory requirements, and industry best practices. Identify and drive continuous quality improvements as a consequence of risk assessments, audits, inspections, trends/metrics and root cause analysis. Provides input into global audit plan based on identified signals/trends/risks/gaps. Ensure rapid communication of critical quality risks and issues, including potential misconduct to business partner and QuRE management. Drive Quality by Design implementation on an asset level. Supports the preparation, execution and close out of health authority inspections. Demonstrates implementation of quality strategy to health authorities Participate/ provides expertise in Due Diligence (in-licensing activities) as applicable.

Leadership/People Management Lead a team of QBP that provides experienced quality support for development (and life-cycle projects). Responsible for talent development, career development, and performance management to ensure resources are appropriately attracted, developed and deployed to deliver the quality strategy. Support the development of annual goals and objectives supporting the strategy. Contributes to the review and revision of the R&D Quality and Risk Management strategy. Leads and/or support functional initiatives as assigned.

Other Maintains the highest level of awareness, expertise in international GLP, GCP and GVP regulations, and internal policies and SOPs. May influence the external environment through interactions with regulators, trade associations or professional societies

Basic Qualifications Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience. Experience in pharmaceutical industry and/or quality assurance. Demonstrated ability to work in an international environment leading global quality team; with previous supervisory/management experience. Knowledge of principles and concepts of quality assurance, (quality) risk management, and quality by design Knowledge of GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational, and planning skills Knowledge in the areas of oncology, immunology, respiratory, vaccine

Preferred Qualifications Experience in supporting regulatory authority inspections. Knowledge of Risk-based quality management, root cause analysis and quality narrative/briefs concepts and methodology Digital savviness, experience with AI/ML and data analytics Ability to work effectively in an international multicultural matrix organization. Effective communication/negotiation skills and customer management skills Experience with Veeva QMS, CTMS and Doc

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 special purpose - to unite science, technology and talent to get ahe d of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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).

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.