Team Lead, Therapeutic Area Quality

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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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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:

• Bachelors 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 $209550 to $349250. If you are based in another US location the annual base salary range is $190500 to $317500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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 compliance with Ontarios 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 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 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 were 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.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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