Lead Regulatory Site Officer - Framingham Quality Compliance
Company: Sanofi
Location: Framingham
Posted on: February 20, 2021
|
|
Job Description:
The health and safety of our employees and candidates is very
important to us. Due to the current situation related to
the--Coronavirus (COVID-19), we're leveraging our digital
capabilities to ensure we can continue to recruit top talent. As
your application progresses, you may be asked to use one of our
digital tools to help you through your recruitment journey. If so,
one of our--colleagues will explain how these tools will be used
throughout the recruitment process and will be on hand to answer
any questions you might have. Lead Regulatory Site Officer -
Framingham Quality Compliance From Research and Development to
Sales and Marketing, Sanofi offers a wide range of possibilities.
Discover our open positions and become a health journey partner. Do
you have what it takes for a successful career with Sanofi? The
department provides leadership, guidance and oversight of the
Quality Policy, Dossier Compliance , External inspections, self
inspection and Risk Management programs for the Framingham
Biologics and Biosurgery site. Lead Maintenance of Dossier
Compliance and Maintenance of the compliance of the
State-of-the-Art for all site product lines. Leadership and
coordination of site external inspection readiness and Regulatory
Authority communication. Functions include: facilitation,
management and support of all site external regulatory inspections;
leadership and coordination of the inspection response; approve and
track inspection commitments; approve Regulatory Authority response
to inquiry, submissions and notifications. Job overview: Lead
project teams to determine the approach for complex maintenance of
Dossier Compliance and State-of-the-Art compliance projects. Ensure
that changes affecting more than one site are evaluated and
approved through the multi-site change control process. Perform gap
analysis of technical documents and determine interrelated impacts
to process and systems. Ensure completeness and correctness of
items such as engineering studies, validation studies, technical
reports, engineering drawings and MBRs/SOPs. Manage regulatory
issues locally at site, supporting improved compliance and
regulatory awareness. Evaluate the regulatory impact of proposed
changes at the sites Communicate proposed CMC changes for
prioritization as necessary to ensure that only Products meeting
all the license requirements are released to market Assist in
maintaining regulatory documents such as Site Master Files.
Coordinate preparation of Product Quality Reviews and Annual
Reports (US market) to ensure that only products meeting all
appropriate testing and release criteria are released to market
--Act as liaison with regulatory authorities, supporting new
product and variation approvals Help support & maintain regulatory
filings Provide regulatory advice (US, EU etc.) and support to the
site, facilitating the introduction of new products, process
technologies and continuous improvement projects. Provide
appropriate resource to the business to meet product release
requirements support of all site external regulatory inspections
Work independently with little or no supervision and exercises
considerable discretion in determining objectives and approaches to
significant organizational project s or assignments Demonstrate an
ongoing commitment to conducting our global business according to
the highest legal and ethical standards, and to continually pursue
excellence in the development and delivery of all of our products
and services. This includes: Adhering to all applicable laws and
regulations of the places in which we conduct business, as well as
our own Company policies and procedures. Being honest and treating
people with respect and courtesy. Constantly striving to make
Sanofi a great place to work, and a company respected for quality
of products and performance of people. Acting as role models for
our fellow employees by acting responsibly, fairly, and honestly in
our dealings and exercising sound judgment in performing our jobs.
Effective operating in an evolving, complex and dynamic
environment, providing clear direction and instruction to teams,
and continuously looking internally and externally for best
practices and areas for improvement Sanofi's leaders motivate,
inspire, build and retain highly effective manufacturing teams
while managing for high performance and developing others. They are
learners and courageous decision makers. Sanofi's leaders are
effective operating in an evolving, complex and dynamic
environment, providing clear direction and instruction to direct
reports, and continuously looking internally and externally for
best practices and areas for improvement. Sanofi's leaders
understand patient and customer needs and build relationships as
required to meet manufacturing goals while continuously improving
operations by setting high standards for the team so they may
perform to a level of excellence. Basic Qualifications: Bachelor's
in Science, Pharmacy or a similar discipline with a minimum of 9
years of experience working in a regulated--cGMP environment OR
Master's in Science, Pharmacy or a similar discipline with a
minimum 6 years of experience working in a regulated cGMP
environment At least 3-4 years' experience in a similar role,
working with international regulatory authorities, with
demonstrated understanding of US and EU regulatory requirements 1-2
years of experience of manufacturing operations Experience working
as in release of products to market Demonstrated ability to
effectively manage all aspects of regulatory projects Experience
participating in international external regulatory health agency
inspections Knowledge of regulatory agency enforcement trends
Experience with project management Preferred Qualifications: Post
Graduate Studies as appropriate to augment Primary Degree
Experience is working with biologics, small molecules, and medical
devices, liaising with regulatory authorities, and working through
Corporate structures highly desirable Sanofi Inc. and its U.S.
affiliates are Equal Opportunity and Affirmative Action employers
committed to a culturally diverse workforce. All qualified
applicants will receive consideration for employment without regard
to race; color; creed; religion; national origin; age; ancestry;
nationality; marital, domestic partnership or civil union status;
sex, gender, gender identity or expression; affectional or sexual
orientation; disability; veteran or military status or liability
for military status; domestic violence victim status; atypical
cellular or blood trait; genetic information (including the refusal
to submit to genetic testing) or any other characteristic protected
by law. #GD-SG
#LI-GZ-- At Sanofi diversity and inclusion is foundational to how
we operate and embedded in our Core Values. We recognize to truly
tap into the richness diversity brings we must lead with inclusion
and have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
all. Join our Talent Network and get Sanofi communications
delivered to your inbox. By submitting your information, you
acknowledge that you have read our privacy policy and consent to
receive email communication from Sanofi.
Keywords: Sanofi, Framingham , Lead Regulatory Site Officer - Framingham Quality Compliance, Other , Framingham, Massachusetts
Click
here to apply!
|
Didn't find what you're looking for? Search again!
Other Other JobsPrivate Tutoring Jobs Concord, New Hampshire Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: Concord Posted on: 02/28/2021 REMOTE DE SAR/LAPP Underwriter - DE, SAR/LAPP, FHA Underwriter Description: If you are a REMOTE DE SAR/LAPP Underwriter with experience, please read on For the last 15 years we have been committed to providing immaculate customer service, from providing hands on assistance and (more...) Company: Optello Location: East Providence Posted on: 02/28/2021 Academic English Private Tutoring Jobs East Providence Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: East Providence Posted on: 02/28/2021 Spanish Private Tutoring Jobs East Providence Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: East Providence Posted on: 02/28/2021 Bather / Groomer Trainee Description: YOUR GROOMING CAREER: Start your career in grooming as a Groomer Trainee As a Groomer Trainee in our Grooming Salon, you'll have the opportunity to build personal relationships with your clients each (more...) Company: PetSmart Location: Concord Posted on: 02/28/2021 Remote Sr. Loan Officer - NMLS Licensed Description: Job DescriptionMinimum Qualifications Must have passed SAFE/UST Licensing Exam Minimum of 1 year of recent, proven success as a Loan Officer in a high-volume setting Minimum of 2 active individual (more...) Company: Quicken Loans Location: East Providence Posted on: 02/28/2021 Algebra Private Tutoring Jobs Concord, New Hampshire Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: Concord Posted on: 02/28/2021 Guitar Private Tutoring Jobs Concord Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: Concord Posted on: 02/28/2021 Hair Stylist - Hooksett Commons Description: StylistAt Great Clips, we know that stylists like you are most happy when they're cutting hair, so at a Great Clips salon, that's exactly what you get to do Want to be the best stylist Company: Great Clips Location: Concord Posted on: 02/28/2021 Chemistry Private Tutoring Jobs Concord, New Hampshire Description: CompanyWe are looking for students, professionals, retirees or anyone with a passion to share, to join the largest community of teachers worldwide If you have free time and want to share your knowledge, (more...) Company: superprof Location: Concord Posted on: 02/28/2021 |