Manufacturing Quality Assurance Manager
Company: Merck
Location: De Soto
Posted on: May 20, 2023
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Job Description:
Job DescriptionOur Quality Assurance Group ensures every single
material inside our products is manufactured, processed, tested,
packaged, stored and distributed aligned with our incredibly high
standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external
contract manufacturers and suppliers we create an interdependent
global manufacturing network dedicated to deliver a compliant,
reliable supply to customers and patients on time, every time,
across the globe.We are seeking a growth and improvement minded
Manufacturing Quality Assurance Manager that can help drive our
Strategic Operating Priorities:Invent - Pursue the Most Promising
Internal and External Science to Address Significant Unmet Medical
NeedsExecute - Prioritize Resources Behind Our Key Growth Drivers
(Oncology, Vaccines, Select Specialty Areas, Animal Health) While
Optimizing Our Base BusinessAdapt - Develop Our People, Culture and
Business Model to Evolve with a Dynamic LandscapeDiverse Talent -
We are committed to providing an inclusive and welcoming
environment with supporting leadership behaviors because having a
high-performing, engaged workforce is critical to our ability to
deliver innovative solutions to patients and customers around the
worldValues and Standards - Our Steadfast Commitment to Our Values
and Standards will Continue to Guide Us as We Take on New
Challenges and Will Always be Fundamental to Our Success - They are
a Competitive Advantage for Us Summary, Focus and Purpose The
selected candidate will provide daily compliance oversight and
guidance to Quality Assurance and Manufacturing personnel.
Responsibilities will include managing systems for manufacturing
deviations, change controls, validations, batch disposition, and
qualification activities against regulatory guidelines and quality
standards.
Key Functions Work Independently and as a Team member with
Integrity - Precision - Accomplishment - Motivational Ambition -
Respect - InclusionLeadership, feedback, and coaching to Quality
Assurance colleagues through routine performance evaluations and
responsibility oversightCompliance oversight and guidance for
upstream and downstream Manufacturing, Engineering/Maintenance and
other departmentsActively contribute to process teams by providing
guidance and oversight in relation to the CFR and Quality
StandardsParticipate in manufacturing walks and internal
auditsOversee disposition of raw materials and liquid
vaccinesQuality systems including Deviations, CAPAs, and Change
ControlsDrives continuous improvement of all quality systems and
processesAssist with or communicate directly through verbal and/or
in writing with regulatory authoritiesParticipates in and provide
direct guidance during external audits and inspectionsOversight of
site Quality Management systemsManage QA budgetCommunicate product
quality problems and provides metrics for the Tier meetings,
Quality Review Council, and Extended Leadership Team meetings
Education Require - High school diploma or equivalentPreferred -
Bachelor or advanced degree Experience - Knowledge - Skills
Required Five plus years of demonstrated leadership, feedback, and
coaching experienceFive plus years in a Quality or Manufacturing
rolePrincipled verbal and written communicationsDemonstrated
ability to lead and work within a teamConsistent decision making
and ability to act according to a strategic planRoot cause analysis
and troubleshooting skillsProficiency with applicable computer
systemsAttention to detail and ability to work within quality
systemsTechnical writing skillsPreferred Working in a regulated
aseptic manufacturing environmentKnowledge of or experience in
Lean, Six-Sigma or Operational ExcellenceOur Manufacturing & Supply
Division is dedicated to being the most trusted supplier of
biopharmaceuticals worldwide. Our facilities, along with our
external contractors, suppliers, and partners, create a reliable
global manufacturing network that's devoted to delivering a
high-quality, reliable supply to customers and patients on time,
every time.Who we are ...We are known as Merck & Co., Inc., Rahway,
New Jersey, USA in the United States and Canada and MSD everywhere
else. For more than a century, we have been inventing for life,
bringing forward medicines and vaccines for many of the world's
most challenging diseases. Today, our company continues to be at
the forefront of research to deliver innovative health solutions
and advance the prevention and treatment of diseases that threaten
people and animals around the world.What we look for ...Imagine
getting up in the morning for a job as important as helping to save
and improve lives around the world. Here, you have that
opportunity. You can put your empathy, creativity, digital mastery,
or scientific genius to work in collaboration with a diverse group
of colleagues who pursue and bring hope to countless people who are
battling some of the most challenging diseases of our time. Our
team is constantly evolving, so if you are among the intellectually
curious, join us-and start making your impact today.NOTICE FOR
INTERNAL APPLICANTSIn accordance with Managers' Policy - Job
Posting and Employee Placement , all employees subject to this
policy are required to have a minimum of twelve (12) months of
service in current position prior to applying for open positions.If
you have been offered a separation benefits package, but have not
yet reached your separation date and are offered a position within
the salary and geographical parameters as set forth in the Summary
Plan Description (SPD) of your separation package, then you are no
longer eligible for your separation benefits package. To discuss in
more detail, please contact your HRBP or Talent Acquisition
Advisor.Employees working in roles that the Company determines
require routine collaboration with external stakeholders, such as
customer-facing commercial, or research-based roles, will be
expected to comply not only with Company policy but also with
policies established by such external stakeholders (for example, a
requirement to be vaccinated against COVID-19 in order to access a
facility or meet with stakeholders). Please understand that, as
permitted by applicable law, if you have not been vaccinated
against COVID-19 and an essential function of your job is to call
on external stakeholders who require vaccination to enter their
premises or engage in face-to-face meetings, then your employment
may pose an undue burden to business operations, in which case you
may not be offered employment, or your employment could be
terminated. Please also note that, where permitted by applicable
law, the Company reserves the right to require COVID-19
vaccinations for positions, such as in Global Employee Health,
where the Company determines in its discretion that the nature of
the role presents an increased risk of disease transmission.Current
Employees apply HERE Current Contingent Workers apply HERE
Secondary Language(s) Job DescriptionOur Quality Assurance group
ensures every single material inside our products is manufactured,
processed, tested, packaged, stored and distributed aligned with
our incredibly high standards of quality and meets all regulatory
requirements. Partnering across our internal manufacturing
facilities, external contract manufacturers and suppliers we create
an interdependent global manufacturing network dedicated to deliver
a compliant, reliable supply to customers and patients on time,
every time, across the globe.We are seeking a growth and
improvement minded Quality Assurance Manager that can help drive
our Strategic Operating Priorities:Invent - Pursue the Most
Promising Internal and External Science to Address Significant
Unmet Medical NeedsExecute - Prioritize Resources Behind Our Key
Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal
Health) While Optimizing Our Base BusinessAdapt - Develop Our
People, Culture and Business Model to Evolve with a Dynamic
LandscapeDiverse Talent - We are committed to providing an
inclusive and welcoming environment with supporting leadership
behaviors because having a high-performing, engaged workforce is
critical to our ability to deliver innovative solutions to patients
and customers around the worldValues and Standards - Our Steadfast
Commitment to Our Values and Standards will Continue to Guide Us as
We Take on New Challenges and Will Always be Fundamental to Our
Success - They are a Competitive Advantage for Us Summary, Focus
and Purpose The selected candidate will provide daily compliance
oversight and guidance to Quality Assurance and Manufacturing
personnel. Responsibilities will include managing systems for
manufacturing deviations, change controls, validations, batch
disposition, and qualification activities against regulatory
guidelines and quality standards.
Key Functions Leadership, feedback, and coaching to Quality
Assurance colleagues through routine performance evaluations and
responsibility oversightCompliance oversight and guidance for
upstream and downstream Manufacturing, Engineering/Maintenance and
other departmentsActively contribute to process teams by providing
guidance and oversight in relation to the CFR and Quality
StandardsParticipate in manufacturing walks and internal
auditsOversee disposition of raw materials and liquid
vaccinesQuality systems including Deviations, CAPAs, and Change
ControlsDrives continuous improvement of all quality systems and
processesAssist with or communicate directly through verbal and/or
in writing with regulatory authoritiesParticipates in and provide
direct guidance during external audits and inspectionsOversight of
site Quality Management systemsManage QA budgetCommunicate product
quality problems and provides metrics for the Tier meetings,
Quality Review Council, and Extended Leadership Team meetings
Education High school diploma or equivalent Experience - Knowledge
- Skills Required Five (5)+ years of demonstrated leadership,
feedback, and coaching experienceFive (5)+ years in a Quality or
Manufacturing rolePrincipled verbal and written
communicationsDemonstrated ability to lead and work within a
teamConsistent decision making and ability to act according to a
strategic planRoot cause analysis and troubleshooting
skillsProficiency with applicable computer systemsAttention to
detail and ability to work within quality systemsTechnical writing
skillsPreferred Bachelor or advanced degreeWorking in a regulated
aseptic manufacturing environmentKnowledge of or experience in
Lean, Six-Sigma or Operational ExcellenceUS and Puerto Rico
Residents Only:Our company is committed to inclusion, ensuring that
candidates can engage in a hiring process that exhibits their true
capabilities. Please click here if you need an accommodation during
the application or hiring process.
For more information about personal rights under Equal Employment
Opportunity, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscriminatio n We are proud to be a company
that embraces the value of bringing diverse, talented, and
committed people together. The fastest way to breakthrough
innovation is when diverse ideas come together in an inclusive
environment. We encourage our colleagues to respectfully challenge
one another's thinking and approach problems collectively. We are
an equal opportunity employer, committed to fostering an inclusive
and diverse workplace. Learn more about your rights, including
under California, Colorado and other US State Acts Search Firm
Representatives Please Read Carefully Merck & Co., Inc., Rahway,
NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA,
does not accept unsolicited assistance from search firms for
employment opportunities. All CVs / resumes submitted by search
firms to any employee at our company without a valid written search
agreement in place for this position will be deemed the sole
property of our company. No fee will be paid in the event a
candidate is hired by our company as a result of an agency referral
where no pre-existing agreement is in place. Where agency
agreements are in place, introductions are position specific.
Please, no phone calls or emails. Employee Status:
RegularRelocation:DomesticVISA Sponsorship:No Travel Requirements:
10%Flexible Work Arrangements:Not SpecifiedShift:1st - DayValid
Driving License:NoHazardous Material(s):N/A
Keywords: Merck, Olathe , Manufacturing Quality Assurance Manager, Executive , De Soto, Kansas
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