Head Quality, R&D & Operations, Boston

As the Head Quality, R&D & Operations, your role will involve providing Site Leadership Team (SLT) strategic partnership and direction in all quality matters to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as GSK corporate quality policies and to ensure successful Quality strategy deployment on site and achievement of objectives. Stake-holder management across GSK for both R&D clinical and commercial deliverables for the site: GSC for PPQ & commercial manufacturing, PAI readiness, approval, and continued supply and with R&D for analytical strategy and clinical manufacturing supply & delivery for the program.

Key Responsibilities

• Operational Quality leadership of the quality organization for both clinical and commercial activities on site and in associated Boston based locations for Clinical and operations activities across GSK.

• Decision making authority and responsibility for presenting the site in health authority interactions.

• Utilizes and cultivates a network across Vaccines and R&D units to build collaborative relationships bringing together product expertise and delivering results.

• Ensure site inspection readiness, assessing the facility & capability needs and manage governance to maintain progress.

• Leads, inspires and engages the workforce in the delivery of site and portfolio milestones.

• Collaborate with Quality organisation to streamline deployment (in place and in use) of GSK's Quality Management System (QMS) fit for purpose to site activities.

• Drive continuous improvement using GPS and proactive review of data and trends and implement the appropriate level of actions.

• Direct all Quality related functions for the site including GMP /non GMP Quality oversight of laboratories, operations oversight and release of product to clinical and commercial markets / clinics.

• Holds cross-functional responsibilities including participation on product development teams for new products and lifecycle issues/changes for commercial products.

• Quality partnership with program strategic PQLs and CMC leaders to connect deliverables for the team.

• Is accountable for adequate Corrective and Preventive Action development arising from any critical or major audit findings and monitoring progress.

• Responsible for the detection, communication and escalation of risks, and subsequent management of mitigation actions.

• Motivate, focus and develop the team in an inclusive environment to build a high performing team.

• Responsible for representing Quality R&D and GSC, providing relevant information to governance boards and one voice of GSK internally and externally.

• Ensures that Site Safety is championed as part of Leadership team, setting high standards for Safety, ensuring that all staff proactively engage in safety conversations

• Leads talent development / talent management activities for Quality staff.

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

• BA/BS or Masters Degree
• Extensive experience in Quality in a highly regulated environment. Proven track record with respect to Product Quality and Compliance, deep knowledge of cGMP globally and new product introduction. Understanding of both the Phase appropriate requirements for clinical supply and commercial PAI requirements for commercial.
• Experience driving simplification and continuous improvement in processes, systems and ways of working that deliver enhanced performance.

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

• MA/MS/MBA/PhD preferred.
• Demonstrated knowledge of compliance with quality systems, legal and regulatory to ensure governance standards are met.
• Experience communicating complex scientific information to non-scientists, including patients & consumers.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/