Senior Manager, External Quality Small Molecules
Company: J&J Family of Companies
Posted on: September 24, 2022
Janssen Supply Group, LLC, a member of Johnson & Johnson's
Family of Companies, is recruiting for a Senior Manager, External
Quality (Small Molecules) located in Raritan, NJ or Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat and
cure disease inspires us. We bring together the best minds and
pursue the most promising science. We are Janssen. We collaborate
with the world for the health of everyone in it. Learn more at
www.janssen.com and follow us @JanssenGlobal. In this position you
will provide end to end quality oversight for external
manufacturers and strategic partners/alliances, ensuring consistent
delivery of pharmaceutical products that meet or exceed safety,
regulatory compliance, and product standards. Key
- Provide quality leadership and technical support to ensure
effective execution of quality systems at external manufacturing
- Manage quality oversight in the selection, qualification, and
ongoing monitoring of external partners
- Lead the identification and resolution of quality issues and
complaints, including facilitation of investigation process and
development of robust CAPA plans.
- Review and approve quality systems documentation, including
product disposition, manufacturing instructions, change controls,
specifications, validation documentation, and technical
- Monitor quality performance through the development of key
performance indicators; analyze data to identify risks and drive
implementation of mitigation plans.
- Build relationships with internal and external partners to meet
patient supply requirements.
- Influence external manufacturers to continuously improve
processes and procedures focused on reliability, execution, and
- Collaborate with external manufacturers to support health
authority inspections; monitor and follow-up on associated response
- Provide oversight for tech transfer and new product
- Partner with external manufacturers to define the quality
strategy through benchmarking and knowledge sharing.
- Lead risk management initiatives necessary to improve
- A minimum of a Bachelor's or equivalent University degree is
required with a focus in life science, engineering, physical
science preferred. Experience and Skills: Required:
- A minimum of 8 years working in an FDA regulated
- Experience with quality support of clinical and commercial
- Experience managing quality oversight for pharmaceutical
- Detailed knowledge of current Good Manufacturing Practices
related to pharmaceutical production.
- Ability to work independently in support of a portfolio of
products and suppliers.
- Ability to quickly process complex information and make
critical decisions with limited information.
- Experience working on and leading cross-functional project
- Strong communication, influencing and leadership skills,
demonstrating an ability to communicate at all levels of the
- Experience working with external partners.
- Experience with product transfer, new product introduction,
medical devices, and advanced therapies.
- Proficient in applying process excellence tools and
- This role may require up to 25% of domestic & international
travel. At Johnson & Johnson, were on a mission to change the
trajectory of health for humanity. That starts by creating the
worlds healthiest workforce. Through cutting-edge programs and
policies, we empower the physical, mental, emotional and financial
health of our employees and the ones they love. As such, candidates
offered employment must show proof of COVID-19 vaccination or
secure an approved accommodation prior to the commencement of
employment to support the well-being of our employees, their
families and the communities in which we live and work. Johnson &
Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, age, national origin, or protected veteran status
and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our
employees throughout their wellness, career and life journey,
please visit www.careers.jnj.com. Primary LocationUnited States-New
Jersey-Raritan-1000 US HIghway 202Other LocationsNorth
America-United States-New Jersey-TitusvilleOrganizationJANSSEN
SUPPLY GROUP, LLC (6046)Job FunctionQualityRequisition
Keywords: J&J Family of Companies, Trenton , Senior Manager, External Quality Small Molecules, Executive , Titusville, New Jersey
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