# Team Lead, Therapeutic Area Quality (GCP / Clinical Quality)

**Company**: GSK
**Experience**: senior
**Job type**: full-time
**Salary**: $209,550 to $349,250
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Pennsylvania-Central/Team-Lead--Therapeutic-Area-Quality_442214?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0cf36101-e12

## Description

GSK has bold ambitions to positively impact the health of 2.5 billion people by the end of the decade. The company's R&D focuses on discovering and delivering vaccines and medicines, combining understanding of the immune system with cutting-edge technology to transform people's lives.

The Team Lead, Therapeutic Area Quality (GCP / Clinical Quality) is responsible for leading a team of Quality Business Partners who provide independent GCP quality oversight and expert support to key stakeholders across clinical trial conduct and R&D programs. This role is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function.

**Responsibilities:**

- Continually evaluate the strategic approach, drive changes in R&D QuRE processes, and modify the quality strategy and plan to meet changing needs.

- Identify and drive continuous quality improvements based on risk assessments, audits, inspections, trends, metrics, and root cause analysis.

- Provide input into the global audit plan based on identified signals, trends, risks, and gaps.

- Ensure rapid communication of critical quality risks and issues to business partners and QuRE management.

- Drive Quality by Design implementation on an asset level across clinical development activities.

- Support preparation, execution, and close-out of health authority GCP inspections.

- Demonstrate implementation of GCP quality strategy to health authorities.

- Participate in Due Diligence activities as applicable.

- Lead a team of QBPs providing experienced GCP quality support for development projects.

- Responsible for talent development, career development, and performance management.

- Support development of annual goals and objectives.

- Contribute to review and revision of R&D Quality and Risk Management strategy.

- Lead or support functional initiatives as assigned.

- Maintain highest level of awareness and expertise in international GCP, GLP, and GVP regulations.

- May influence external environment through interactions with regulators, trade associations, or professional societies.

**Requirements:**

- Bachelor's degree or equivalent in a scientific or quality-related field.

- Demonstrated expertise in Good Clinical Practice (GCP) and clinical trial quality oversight.

- Experience in pharmaceutical industry and/or clinical quality assurance.

- Demonstrated ability to work in an international environment leading a global quality team.

- Minimum of 3 years supervisory/management experience.

- Demonstrated knowledge of quality assurance, risk management, and quality by design.

- Broad knowledge in areas of oncology, immunology, respiratory, vaccines.

- Experience with Veeva QMS, CTMS, and related clinical quality documentation systems.

**Preferred Qualifications:**

- Extensive experience in supporting regulatory authority GCP inspections.

- Broad knowledge of risk-based quality management, root cause analysis, and quality narrative/briefs concepts.

- 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.

**Salary:** For US locations, the annual base salary for new hires in this position ranges $209,550 to $349,250.

**Benefits:** Available benefits include health care and other insurance benefits, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

## Skills

### Required
- Good Clinical Practice (GCP)
- clinical trial quality oversight
- quality assurance
- risk management
- quality by design
- Veeva QMS
- CTMS

### Nice to have
- AI/ML
- data analytics
- digital savviness
- risk-based quality management
- root cause analysis

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Pennsylvania-Central/Team-Lead--Therapeutic-Area-Quality_442214?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)