Senior Manager, QA - Validation
Posted on: January 21, 2023
Site Name: Cambridge Binney Street
Posted Date: Jan 11 2023
We make and supply medicines and vaccines all around the globe and
our teams own every production stage, from creating quality
products at our manufacturing sites to designing effective supply
forecasting and regulatory inspections; all powered by digital,
data and analytics. We operate at impressive scale, producing over
1.7 billion packs of medicine and 767 vaccine doses in 2021.
We continue to modernise, so we can launch even more new products
at speed whilst turbo-charging delivery across our entire portfolio
through our relentless focus on quality, safety, and service. The
way we work will change. For some, the shift in technology and
products will be revolutionary. Our R&D pipeline demands a new
kind of supply chain, and we need the very best minds and
capability to help us on our journey to make more complex products,
harnessing the power of automation and robotics so we can work
We're looking for an exceptional Senior Manager, QAV, to join the
Quality Assurance team. With excellent technical, operations,
communication, and quality assurance skills, you'll be given the
opportunity to work directly with Manufacturing, Facilities,
Engineering, Validation and QC staff to review and approve
validation related documents.
- Provide quality and compliance oversight for Commissioning,
Qualification, Validation of Facilities, Utilities, Systems and
- Review and approve project plans, SIA's, URS's, DQ's, RA's,
Validation protocols, Summary reports, SOPs, Specifications, and
other applicable validation documentation.
- Work with a cross-functional team on validation related
Deviations, CAPAs, and Change Controls.
- Support technical and quality investigations.
- Provide guidance to other employees in the interpretation of
quality issues and participate in the development of technical or
scientific initiatives and activities.
- Collaborates with functional departments to resolve
- Demonstrate understanding and knowledge of Equipment
Qualification, Utilities Monitoring and Qualification, SIP/CIP
Validation, Lab Instrumentation Qualification, CSV.
- Additional duties and responsibilities as required.
Why you? Basic Qualifications:
- 5+ years of industry experience in QA or Validation for a
- Proficiency with MS Office- Word formatting. Excel for analysis
- Excellent written and oral presentation skills.
- Creative thinking, multi-tasking and ability to work in a
- A Bachelor's degree (or higher) in Chemistry, Biology,
Engineering, or related field.
We want GSK to be a workplace where everyone can feel a sense of
belonging and thrive. 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.
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
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.
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.
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
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
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 GSK's Transparency Reporting For the Record site.
Keywords: GSK, Cambridge , Senior Manager, QA - Validation, Executive , Cambridge, Massachusetts
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