Associate Director QA – Quality Systems and Compliance
Site Name: Cambridge Binney Street
Posted Date: Feb 8 2023
Your responsibilities include some of the following:
- Define and deploy GSK Quality Assurance standards and ensure compliance the Binney Street site.
- Own and improve the Quality Management System and assist with new system deployments.
- Manage the Training department.
- Manage the Documentation Control department.
- Develop/maintain the site inspectional readiness program.
- Monitor regulatory changes and ensure compliance to the applicable regulations.
- Maintain site related Quality Metrics/KPIs to present at QMR.
- Ensure material manufactured at the Binney Street site adheres to the IND/BLA.
- Responsible for all potential complaints/recalls for material manufactured at Binney Street.
- Provide leadership for change initiatives involving processes, methods, technologies and people which contribute to the overall effective improvement of GSK Vaccines Quality.
- Focus on People management, succession planning and team development. Lead, train, coach and motivate your team.
We are looking for professionals with these required skills to achieve our goals:
- University degree in Manufacturing/Science, Engineering, Quality or a relevant scientific discipline
- 12+ years experience in a pharmaceutical / sterile operation / biological production environment
- 6+ years experience in Quality, with substantial knowledge of regulatory, GMP, QC, sterile manufacturing and legal requirements
If you have the following characteristics, it would be a plus:
- Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
- Executive and leadership capability to manage people
- Strong Interpersonal skills and developed knowledge of data integrity
- Ability to think through the process and accurately apply and adapt regulatory standards
- Helpful to understand the QA function with the ability to make decisions on a go / no go criteria
- The ability to work effectively within a variety of situations and adapt enthusiastically to changes in job demands
- Pursues tasks with energy, drive, and initiative; even in a fast-paced environment
- Comfortable in a results-driven, highly accountable environment where you can make an impact
- Builds productive working relationships across key groups
- Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 Get Ahead 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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