Team Lead, Therapeutic Area Quality

Please note that this is a ‘internal job posting’ link, intended for GSK/ViiV employees only. Contingent Workers should check with the recruiter of the Job Requisition to confirm whether the job is open to contingent workers and to obtain the correct job posting hyperlink.

Please note it is your responsibility to notify your manager if you are interested in applying to an open position prior to the interview taking place. Please refer to your local policy for more information and guidelines.

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.

Find out more:

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.





 


If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please submit a request to HR via the Service Portal

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.

This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.

Compensation Grade:

4

Job Posting End Date:

Not Available

Eligible for Employee Referral Bonus:

Yes