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. 
• Flexible thinking and risk-based approach methodology adept. 
• Excellent oral and written communication skills. Problem identification and solving skills. 
• Strong interpersonal skills with an ability to enable and drive change. 
• Ability to adapt, work under uncertainty and accommodate flexible work demands

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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