Sr Manager, Quality Assurance
Company: Nestle Health Science
Posted on: May 15, 2022
As a leader in the science of nutrition, Nestle Health Science
believes in empowering healthier lives for patients and consumers
through a rich product portfolio featuring top brands such as
Garden of Life, Natures Bounty, Vital Proteins, Nuun, Persona
Nutrition, BOOST, Carnation Breakfast Essentials, Peptamen,
Compleat Organic Blends, and more, as well as through Aimmune
Therapeutics, a biopharmaceutical company developing therapies to
prevent, manage and treat food, GI and metabolic-related
Our team members are challenged to make a genuine impact and play
an integral role in driving the business forward. We embrace a
dynamic culture that always puts the consumer first, and where
ownership, accountability and agility are celebrated at every
level. To help our people thrive, we offer expansive career growth
potential, the opportunity to work alongside and learn from
talented colleagues with diverse backgrounds and skill sets, and a
range of best-in-class benefits.
We have more than 11,000 employees around the world, and products
available in over 140 countries.
This position is not eligible for Visa Sponsorship.
Position SummaryProvide Quality oversight of cGMP operations
performed for Aimmune at Contract Manufacturing Organizations
(CMOs) and/or Contract Testing Labs (CTLs) per the global
regulatory requirements.Specific Responsibilities:
- Provide Quality oversight and leadership for cGMP activities
related to Aimmunes early development products produced at
- Work directly with operating entities (internal and CMOs/CTLs)
to ensure that clinical drug substance and drug products meet all
required quality standards and specifications or are appropriately
- Provide effective QA support for the manufacturing and
disposition of clinical drug product lots.
- Review and approve internal and CMO/CTL deviations, OOS, lab
investigations, change controls.
- Review and approve the CMO/CTL Specifications, Test Methods,
Analytical Method Validation Protocols/Reports and Stability
Protocols/Reports as assigned.
- Work with CMOs/CTLs to ensure that policies at CMOs/CTLs adhere
to cGMPs and regulatory requirements of FDA, EMA and other
regulatory agencies, as required.
- Demonstrate proven strategies for coping with early-stage
product development including the ability to be flexible with
requirements based on phase appropriateness.
- Ensure that Quality policies and practices at CMOs/CTLs adhere
to approved quality agreements, monitor, and provide corrective
action recommendations to compliance issues and/or observations as
they arise. Manage and coordinate process monitoring and continuous
improvement initiatives as per cGMP requirements, as required.
- Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a
technical discipline (physical, engineering, chemical or biological
sciences) is required.
- 5+ years experience in a cGMP regulated environment, with
exhibited knowledge or proficiency in Quality Assurance.
- Organizational and management skills to communicate to
multi-discipline project groups.
- Ability to speak, present data, and defend approaches in front
of audiences and inspectors.
- Ability to comprehend technical information and regulatory
- Proficiency with Office software applications, including MS
Word, MS Excel, MS Project, MS Power Point.
- Proficiency with technical summary report reviews required,
with exceptional organizational attention to detail.
- Knowledge of industry standards, guidance documents, and global
regulatory requirements from Phase I to Phase III is
required.Experience with responding to EU Qualified Person requests
is a plus.
It is our business imperative to remain a very inclusive
To our veterans and separated service members, you're at the
forefront of our minds as we recruit top talent to join Nestle. The
skills you've gained while serving our country, such as
flexibility, agility, and leadership, are much like the skills that
will make you successful in this role. In addition, with our
commitment to an inclusive work environment, we recognize the
exceptional engagement and innovation displayed by individuals with
disabilities. Nestle seeks such skilled and qualified individuals
to share our mission where youll join a cohort of others who have
chosen to call Nestle home.
The Nestle Companies are an equal employment opportunity and
affirmative action employer seeking diversity in qualified
applicants for employment. All applicants will receive
consideration for employment without regard to race, ethnicity,
color, gender, gender identity, age, religion, national origin,
ancestry, disability, perceived disability, medical condition,
genetic information, veteran status, sexual orientation, or any
other protected status, as defined by applicable law. Prior to the
next step in the recruiting process, we welcome you to inform us
confidentially if you may require any special accommodations in
order to participate fully in our recruitment experience. Contact
us at firstname.lastname@example.org or please dial 711 and provide this
number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
Brisbane, CA, US, 94005by Jobble
Keywords: Nestle Health Science, San Francisco , Sr Manager, Quality Assurance, Executive , Brisbane, California
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