Team Lead, Therapeutic Area Quality - #2084140

442214

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

Position Summary:

The Team Lead, Therapeutic Area Quality is responsible for leading a team of Quality Business Partners that deliver independent quality expert support to key stakeholders. This individual is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function. This individual 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

Job Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.
• 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.
• 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

Why You?

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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; minimum of 3 years supervisory/management experience.
• Demonstrated knowledge of principles and concepts of quality assurance, (quality) risk management, and quality by design
• Demonstrated knowledge of GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational, and planning skills
• Broad knowledge in the areas of oncology, immunology, respiratory, vaccine

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Extensive experience in supporting regulatory authority inspections.
• Broad 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

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $209,550 to $349,250. If you are based in another US location, the annual base salary range is $190,500 to $317,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.In

compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD0 to CAD0 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

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...