Quality R&D analytical labs Associate Director US

Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development?  If so, this Quality R&D analytical labs Associate Director US (Upper Providence) role could be a great opportunity to explore.

As a Quality R&D analytical labs Associate Director US, you will be responsible to serve as a compliance authority to ensure quality oversight and compliance within the Analytical Development team, supporting development and GMP analytical activities at US sites. Ensure lab activities are conducted in accordance with GMP, local, corporate, and relevant international regulations. Foster a culture of continuous improvement and compliance. Manage stakeholder relationships to ensure effective communication with global R&D and maintain a unified quality voice with Quality teams.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing program, pension plan membership, and shares and savings program.

We embrace modern work practices; our Performance with Choice program offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will:

• Act as a compliance authority, providing fit-for-purpose quality oversight and maintaining quality standards from method development to release testing by performing Gemba walks, coaching, and reviewing critical documents.
• Oversee Deviation, Corrective and Preventive Actions (CAPA), and Change Control processes, and perform operational quality oversight on laboratory operations.
• Manage and escalate issues appropriately to ensure timely and effective resolution, and drive quality initiatives to foster a quality culture and mindset.
• Ensure quality practices are fit-for-purpose and aligned across all supported analytical departments, providing risk-proportioned quality input to processes and systems.
• Perform shared quality activities linked to the site, such as Management Monitoring review and audit facilitation, and support local and global QR&D projects and support local and global QR&D projects, such as R&D QMS implementation.
• Prepare and support the R&D functions for audits conducted by GSK and/or external Health Authorities.

Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• University (Master) degree in sciences or equivalent, analytical expertise.
• 8+ years of experience in a quality or compliance role within the pharmaceutical or biotechnology industry, with a focus on R&D.
• Experience in a quality or compliance role within the pharmaceutical or biotechnology industry, with a focus on R&D.
• knowledge in quality regulation requirements covering GMP and general quality compliance. 
• Experience in managing and leading quality activities in an R&D environment, including audit facilitation and quality system implementation.

Preferred Qualifications & Skills:

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

• Strong interpersonal skills with an ability to enable and drive change. 
• In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation Ability to manage networks and build relationships transversally across the network. Experience of working with multi-functional teams. 
• Excellent oral and written communication skills. Problem identification and solving skills. 
• Flexible thinking and risk-based approach methodology adept. 
• Analytical expertise
• Proven experience in managing and leading quality activities in an R&D environment, including audit facilitation and quality system implementation.
• Deep knowledge in quality regulation requirements covering GMP and general quality compliance.  In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation
• Excellent problem-solving skills and the ability to make data-driven decisions.
• Ability to manage networks and build relationships transversally across the network. Experience of working with multi-functional teams. <