Head, Third Party Quality (Senior Director)

Site Name: GSK HQ, Stevenage, USA - Pennsylvania - Upper Providence
Posted Date: Nov 7 2024

Head – Third Party Quality

Job Purpose

The Head, Third Party Quality is a critical management position within the R&D Business Partner Quality organisation that is responsible for the development and strategic oversight of the third-party quality activities. The position provides leadership for the identification and resolution of critical quality issues that may affect GSK. The Head, Third Party Quality is responsible for the strategic alignment with development operation, procurement and Business Units regarding management and oversight of R&D Third Parties.

Key Responsibilities

Functional Expertise

1. Develops and implements quality strategy to oversee and manage third parties’ activities.
2. Oversees third party quality oversight activities including qualification, quality governance and quality agreements.
3. Identifies areas of risks through active participation in risk-based Quality assessments for third parties.
4. Collaborates and partners with the Quality Auditing group to deliver global audits and assessments.
5. Works with Quality Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders.
6. Ensures ongoing inspection readiness in the area of responsibility and implements required activities.
7. Participates in preparation, execution and close out of health authority inspections in collaboration with Inspection Management.
8. Provides quality advice and GxP expertise within the functional & process area.
9. Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.
10. Supports the investigations of potential serious breaches and critical issues.
11. Shares key learnings to drive simplification and replicate best practices to drive quality into the business.

Talent Development/Management

1. Builds and maintains a Third-Party Quality team by creating an environment that attracts, develops and retains high-quality employees.
2. Provides leadership, professional development, mentoring and coaching for direct and indirect reports, including talent planning and performance management.
3. Develops, motivates, and empowers direct reports to have a high degree of accountability for performance and the oversight of key deliverables.

Other

1. Leads multidisciplinary or cross-functional work/project teams.
2. Provides guidance and expectations to the business to enable execution of external regulations and internal standards on a global and cross-functional level.
3. Manages a fiscally responsible team budget including operating expenses, staffing level and outside collaborations.
4. May influence the external environment through interactions with regulators, trade associations, and professional societies.
5. Provides input into the global audit plan based on identified signals/trends/risks/gaps.
6. Liaises with stakeholders in R&D to understand global and local needs and determine priorities.

WHY YOU?

Basic Requirements

1. Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
2. Experience in drug development, regulatory compliance or quality management.
3. Experience in clinical, medical, pharmacovigilance or regulatory quality.
4. Knowledge of GLP, GCP, GVP and regulatory requirements.
5. Experience in TP alliance management.

Preferred Qualifications

1. Broad working knowledge/expertise in principles and concepts of quality by design, risk management and quality positions.
2. Solid working knowledge in continuous improvement with a background in the appropriate tools.
3. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
4. Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
5. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments.
6. Effective communication/negotiation skills and customer management skills.
7. Demonstrated knowledge of Veeva QMS.
8. Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.
9. Proven problem-solving skills to prevent and overcome complex process and quality-related issues.
10. Broad understanding of digitalization and decentralized clinical trial elements.
11. Proven track record of building/maintaining high performance teams.
12. External engagement with industry/trade/quality organisations.

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 ahead 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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

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.